Acute Kidney InjuryPhase 2NCT02772276
Pharmacokinetics of MB-102 and Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types
A Phase 2 study testing MB-102-- single dose of 4 µmol/kg, MB-102-- single dose of 130 mg and MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart in people with Acute Kidney Injury, run by MediBeacon at 3 sites in United States.
Trial summary
This study was a pilot, safety, and pharmacokinetic study of MB-102 versus iohexol and the use of the non-invasive optical renal function monitor (ORFM) device in normal and compromised renal function participants with different skin color types. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- MB-102-- single dose of 4 µmol/kg, MB-102-- single dose of 130 mg and MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 May 2016to 4 Aug 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Main Criteria for Inclusion (Quantum Leap and Radiance device)
- Age > 22 years - male or female
- Eligible female non-pregnant participants who are either not of childbearing potential or willing to use adequate contraception during the trial
- Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post dose
- Participants willing to comply with study requirements
- Participants who have signed an informed consent form
Show all 33Show fewer
- Normal or non-clinically significant screening and baseline 12-lead electrocardiogram (ECG) in the opinion of the principal investigator (PI)
- Adequate venous access sufficient to allow blood sampling per protocol requirements
- Main Criteria for Inclusion (Brilliance device)
- Age > 18 years - male or female
- Eligible female non-pregnant participants who are either not of childbearing potential or willing to use adequate contraception during the trial
- Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post dose
- Participants willing to comply with study requirements
- Participants who have signed an informed consent form
- Normal or non-clinically significant screening and baseline 12-lead ECG in the opinion of the PI
- Adequate venous access sufficient to allow blood sampling per protocol requirements
- Normal-CKD Stage 2/QuantumLeap; Normal-CKD Stage 2/Radiance; Normal-CKD Stage 2/Brilliance algorithm optimization; Normal-CKD Stage 2/Brilliance sensor optimization; Normal-CKD Stage 2/Brilliance sensor optimization; and Normal-CKD Stage 2/Brilliance (1-2 sensors)
- Are healthy as determined by medical history, with no clinically significant findings on screening and baseline physical exams, vital signs and clinical laboratory panels or conditions that could adversely impact the participant's participation or safety, conduct of the study or interfere with study assessments
- Have estimated glomerular filtration rate (eGFR (Chronic kidney disease - epidemiology collaboration [CKD-EPI] equation) of ≥60 ml/min/1.73m^2 (normal to Stage 2 CKD) at the time of screening
- Approximately half of the participants enrolled in each cohort to have Fitzpatrick Scale Type I, II or III skin color type
- Approximately half of the participants enrolled in each cohort to have Fitzpatrick Type IV, V or VI skin color type.
- CKD Stage 3-4/QuantumLeap
- Possess stable renal function in the opinion of the PI
- Have eGFR (CKD-EPI equation) of 15 - 59 mL/min/1.73m^2 at the time of screening
- Stable use of immunosuppressant medications (when applicable)
- 15 participants per cohort to have Fitzpatrick Type I, II or III skin color type
- 15 participants per cohort to have Fitzpatrick Type IV, V or VI skin color type
- CKD Stage 3-5/Radiance; CKD Stage 3-5/Brilliance algorithm optimization; CKD Stage 3-5/Brilliance sensor validation; and CKD Stage 3-5/Brilliance 1-2 sensors
- Possess stable renal function as defined as the most recent historical (within 3 months) eGFR and screening eGFR differing by ≤20%.
- Have eGFR (CKD-EPI equation) of <59 mL/min/1.73m^2 based on a historical value collected within 3 months or from the screening serum creatinine
- Stable use of immunosuppressant medications (when applicable) defined as no changes in the last 30 days or expected through the follow up visits, and a prednisone dose of <20 mg/day (or another steroid's equivalent dose)
- Approximately half of the participants in each cohort to have Fitzpatrick Type I, II or III skin color type
- Approximately half of the participants in each cohort to have Fitzpatrick Type IV, V or VI skin color type
Who cannot join
- Main Criteria for Exclusion (QuantumLeap device)
- Women who are pregnant, lactating or planning to become pregnant during the study, or women who are of childbearing potential unwilling to use a barrier method of birth control
- Intolerant to venipuncture
- Recent donation or loss of blood or plasma: 100 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication
- Participation in another interventional trial within 30 days of screening or concurrently enrolled in any other medical research study which could impact the results of the study
- History of drug or alcohol abuse within the past year
Show all 75Show fewer
- History of allergy or hypersensitivity to MB-102 or iohexol, or other related (iodinated contrast media) products, or any of the inactive ingredients
- History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the PI, could contraindicate the subject's participation in this study
- Participants who have allergies to 2 or more classes of drugs. (Intolerance to a drug is not considered a drug allergy)
- Stable use (no changes within 30 days) of prescription or over the counter (OTC) medications
- Non-steroidal anti-inflammatory drug (NSAID) use within 2 days of dosing day
- History of coagulation disorders or bleeding disorders that in the judgement of the investigator places the subject at undue risks for study related procedures
- Are homozygous for sickle cell disease
- Have a known thyroid disorder
- Have pheochromocytoma
- Currently on Coumadin (warfarin) who have an International normalized ratio (INR) >4 at Screening
- Current history of AIDS or HIV
- Hepatitis B antigen positive, or C antibody positive
- Site personnel immediately associated with the study or their immediate family members
- Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial
- Prior enrollment and dosing in this Pilot 2 study
- Significant scaring, tattoos or alterations in pigmentation on the sternum that would alter sensor readings versus other areas of the skin
- Additional Exclusion: Normal-CKD Stage 2/QuantumLeap
- History of significant cardiovascular disease, heart failure, myocardial infarction in the past 3 months, pulmonary, hematologic, endocrine, hepatobiliary, nephrologic, immunologic, dermatologic, neurologic (including any history of stroke and/or seizure disorder), psychological, musculoskeletal disease, diagnosis of cancer with the past 2 years or deemed clinically significant or unstable by the Principal Investigator; Note: history of gallstones or kidney stones are not excluded so long as the condition is not acute within 30 days of dosing.
- Additional Exclusion: CKD Stage 3-4/QuantumLeap
- Stage 5 CKD at the time of screening
- Recent (within 3 months) significant medical condition or surgical procedure including myocardial infarction, laparoscopic procedures, or other medical inventions
- Doses of prednisone greater than 10 mg/day within the last 90 days
- Main Criteria for Exclusion: (Radiance device)
- Women who are pregnant, lactating or planning to become pregnant during the study, or women who are of childbearing potential unwilling to use a barrier method of birth control
- o Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post dose
- Unable to have venous access placed in both arms
- Recent donation or loss of blood or plasma: 100 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication
- Participation in another interventional trial within 30 days of dosing or concurrently enrolled in any other medical research study which could impact the results of the study
- History of drug or alcohol abuse within the past year
- History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
- History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, MB-102 and iohexol or other related (iodinated contrast media) products (intolerance to a drug is not considered a drug allergy)
- NSAID use within 2 days of dosing day
- History of coagulation disorders or bleeding disorders that in the judgement of the investigator places the subject at undue risks for study related procedures
- Are homozygous for sickle cell disease
- Have hyperthyroidism or current thyroid cancer
- Have pheochromocytoma
- Currently on Coumadin (warfarin) who have an INR >4 at Screening
- Current history of AIDS or HIV
- Current evidence of an active Hepatitis B or C infection. If the participant is Hepatitis C antibody positive, but the hepatitis C RNA is below the level of detection, they are considered immune and may be eligible for enrollment.
- Site personnel immediately associated with the study or their immediate family members
- Any characteristics which, in the opinion of the investigator, makes the subject a poor candidate for participation in the clinical trial
- Prior exposure to MB-102
- Significant scaring, tattoos or alterations in pigmentation on the sternum that would alter sensor readings versus other areas of the skin
- Main Criteria for Exclusion: (Brilliance device)
- Women who are pregnant, lactating or planning to become pregnant during the study, or women who are of childbearing potential unwilling to use a barrier method of birth control
- o Males must be unwilling to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post dose
- Unable to have venous access
- Recent donation or loss of blood or plasma: 100 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication
- Participation in another interventional trial within 30 days of dosing or concurrently enrolled in any other medical research study which could impact the results of the study
- History of drug or alcohol abuse within the past year
- History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
- History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, or MB-102 (intolerance to a drug is not considered a drug allergy)
- NSAID use within 2 days of dosing day
- History of coagulation disorders or bleeding disorders that in the judgement of the investigator places the subject at undue risks for study related procedures
- Currently on Coumadin (warfarin) who have an INR >4 at Screening
- Current history of AIDS or HIV
- Current evidence of an active Hepatitis B or C infection. If the participant is Hepatitis C antibody positive, but the hepatitis C RNA is below the level of detection, they are considered immune and may be eligible for enrollment.
- Site personnel immediately associated with the study or their immediate family members
- Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial
- Significant scaring, tattoos or alterations in pigmentation on the sternum that would alter sensor readings versus other areas of the skin
- Additional Exclusion: Normal-CKD Stage 2/Radiance; Normal-CKD Stage 2/Brilliance algorithm optimization; Normal-CKD Stage 2/Brilliance sensor optimization; Normal-CKD Stage 2/Brilliance sensor validation; and Normal-CKD Stage 2/Brilliance (1-2 sensors)
- History of significant cardiovascular disease, heart failure, myocardial infarction in the past 3 months, or NYHA class III or IV HF
- Any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, or psychiatric condition that in the opinion of the investigator would limit the participant's ability to complete study requirements or may put the subject at increased risk or compromise interpretability of study results. Note: a history of gallstones or kidney stones are not excluded so long as the condition is not acute within 30 days of dosing.
- Additional Exclusion: CKD Stage 3-5/Radiance; CKD Stage 3-5/Brilliance algorithm optimization; CKD Stage 3-5/Brilliance sensor validation; and CKD Stage 3-5/Brilliance 1-2 sensors
- Recent (within 3 months) significant medical condition or surgical procedure including myocardial infarction, thoracic laparoscopic procedures, or other significant medical inventions
- Received >20 mg/day of prednisone or an equivalent dose of glucocorticoid for more than 7 days in the last 90 days prior to dosing day for an acute or chronic disorder
- Currently receiving dialysis
- Currently anuric
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Riverside Clinical Research
Edgewater, Florida, 32132
Orlando Clinical Research Center
Orlando, Florida, 32809
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Pilot Safety and Pharmacokinetic Study of MB-102 Versus Iohexol and the Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types
This study was a pilot, safety, and pharmacokinetic study of MB-102 versus iohexol and the use of the non-invasive optical renal function monitor (ORFM) device in normal and compromised renal function participants with different skin color types.
Read the detailed description
The objectives of this study were to evaluate the safety and tolerability of single and multiple doses of MB-102 in participants with normal and impaired kidney function; to determine plasma pharmacokinetics of MB-102 compared to the pharmacokinetics of iohexol in participants with normal and impaired kidney function; to demonstrate that MB-102-transdermal-fluorescence-measured glomerular filtration rate (GFR) using the optical renal function monitor (ORFM) Brilliance device is aligned with MB-102 plasma GFR; to evaluate the safety and effectiveness of the ORFM investigational medical device prototypes QuantumLeap, Radiance, and Brilliance for the non-invasive transdermal fluorescent detection of MB-102 in participants with a range of skin color types; and to determine the optimal dose of MB-102 for non-invasive measurement.
- Conditions
- Acute Kidney Injury
- Being tested
- MB-102-- single dose of 4 µmol/kg, MB-102-- single dose of 130 mg, MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart, MB-102-- two doses of 130 mg 24 hours apart, Iohexol
- Keywords
- Glomerular Filtration Rate
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB-102-- single dose of 4 µmol/kgDrug
Also called Relmapirazin
4 µmol/kg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds.
MB-102-- single dose of 130 mgDrug
Also called Relmapirazin
130 mg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds. A subset of participants will receive two doses of MB-102, 12 hours apart.
MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apartDrug
Also called Relmapirazin
130 mg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds.
MB-102-- two doses of 130 mg 24 hours apartDrug
Also called Relmapirazin
4 µmol/kg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds. A subset of participants will receive two doses of MB-102, 12 hours apart.
IohexolDrug
Also called Omnipaque 300
5 mL of a 647 mg/mL solution administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds
QuantumLeapDevice
Optical Renal Function Monitor (ORFM)
RadianceDevice
Optical Renal Function Monitor (ORFM)
Brilliance (1 or 2 sensors)Device
Optical Renal Function Monitor (ORFM)
Brilliance (2-part sensor)Device
Optical Renal Function Monitor (ORFM)
| Study group | Role | What they receive |
|---|---|---|
| Normal-CKD Stage 2/QuantumLeap | Experimental | MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses. Receives: Drug: MB-102-- single dose of 4 µmol/kg; Drug: Iohexol; Device: QuantumLeap |
| CKD Stage 3-4/QuantumLeap | Experimental | MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses. Receives: Drug: MB-102-- single dose of 4 µmol/kg; Drug: Iohexol; Device: QuantumLeap |
| Normal-CKD Stage 2/Radiance | Experimental | MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Radiance ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. Receives: Drug: MB-102-- single dose of 4 µmol/kg; Drug: Iohexol; Device: Radiance |
| CKD Stage 3-5/Radiance | Experimental | MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Radiance ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. Receives: Drug: MB-102-- single dose of 4 µmol/kg; Drug: Iohexol; Device: Radiance |
| Normal-CKD Stage 2/Brilliance algorithm optimization | Experimental | MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Algorithm optimization of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. Receives: Drug: MB-102-- single dose of 4 µmol/kg; Device: Brilliance (1 or 2 sensors) |
| CKD Stage 3-5/Brilliance algorithm optimization | Experimental | MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. Algorithm optimization of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. Receives: Drug: MB-102-- single dose of 4 µmol/kg; Device: Brilliance (1 or 2 sensors) |
| Normal-CKD Stage 2/Brilliance sensor optimization | Experimental | MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Sensor optimization of the Brilliance device was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. Receives: Drug: MB-102-- single dose of 4 µmol/kg; Device: Brilliance (1 or 2 sensors) |
| Normal-CKD Stage 2/Brilliance sensor validation | Experimental | MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Validation of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. Receives: Drug: MB-102-- single dose of 4 µmol/kg; Device: Brilliance (1 or 2 sensors) |
| CKD Stage 3-5/Brilliance sensor validation | Experimental | MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. Validation of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. Receives: Drug: MB-102-- single dose of 130 mg; Device: Brilliance (1 or 2 sensors) |
| Normal-CKD Stage 2/Brilliance (1-2 sensors) | Experimental | MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. A subset of participants in this arm received two doses of MB-102, 12 hours apart. Receives: Drug: MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart; Device: Brilliance (1 or 2 sensors) |
| Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor) | Experimental | MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors and 2-part sensor). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. A subset of participants in this arm received two doses of MB-102, 12 hours apart. Receives: Drug: MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart; Device: Brilliance (1 or 2 sensors); Device: Brilliance (2-part sensor) |
| Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor) and 2 doses MB-102 | Experimental | Two doses of MB-102 administered to participants 12 hours apart, with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors and 2-part sensor). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. Receives: Drug: MB-102-- two doses of 130 mg 24 hours apart; Device: Brilliance (1 or 2 sensors); Device: Brilliance (2-part sensor) |
| CKD Stage 3-5/Brilliance 1-2 sensors | Experimental | MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. Receives: Drug: MB-102-- single dose of 130 mg; Device: Brilliance (1 or 2 sensors) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events
An adverse event is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, temporally associated with the use of a medicinal product, whether or not related to the investigational medical device or drug.
Measured: From the time of dosing through the follow-up visit, up to 10 days
Secondary outcomes (23)
Maximum Plasma Concentration (Cmax) of MB-102
Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.
Measured: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Maximum Plasma Concentration (Cmax) of Iohexol
Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.
Measured: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Time to Maximum Plasma Concentration (Tmax) of MB-102
Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in minutes) was directly determined from the concentration-time data.
Measured: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Time to Maximum Plasma Concentration (Tmax) of Iohexol
Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in minutes) was directly determined from the concentration-time data.
Measured: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
The Elimination Half-life of MB-102
Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The elimination half-life (the time required for the concentration of the drug to reach half of its original value) was calculated as t1/2 λz= ln(2)/ λz.
Measured: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
The Elimination Half-life of Iohexol
Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The elimination half-life (the time required for the concentration of the drug to reach half of its original value) was calculated as t1/2 λz= ln(2)/ λz.
Measured: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102
Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng*min/mL) was be estimated from time 0 to the last measurable concentration using noncompartmental analyses.
Measured: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Iohexol
Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng*min/mL) was be estimated from time 0 to the last measurable concentration using noncompartmental analyses.
Measured: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102
Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng*min/mL) from time 0 to infinity was calculated as: AUC∞ = AUClast + LQC/λz where LQC is the predicted concentration (based on the terminal regression) at the time of the last measurable concentration.
Measured: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Iohexol
Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng*min/mL) from time 0 to infinity was calculated as: AUC∞ = AUClast + LQC/λz where LQC is the predicted concentration (based on the terminal regression) at the time of the last measurable concentration.
Measured: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Total Plasma Clearance of MB-102
Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Total plasma clearance (the volume of plasma cleared of the drug over time) was calculated as: Clp = Dose/ AUC∞.
Measured: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Total Plasma Clearance of Iohexol
Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Total plasma clearance (the volume of plasma cleared of the drug over time) was calculated as: Clp = Dose/ AUC∞.
Measured: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
The Terminal Rate Constant for MB-102
Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The terminal rate constant (λz) was determined by linear regression of the terminal linear phase of the log plasma concentration-time profile.
Measured: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
The Terminal Rate Constant for Iohexol
Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The terminal rate constant (λz) was determined by linear regression of the terminal linear phase of the log plasma concentration-time profile.
Measured: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Renal Clearance of MB-102
Urine samples were collected pre-dose (time 0) and 5 mL urine samples were collected each time the subject voided. The total volume of urine excreted was recorded until 12 hours post-dose, and was analyzed using validated analytical methods. Renal clearance (the volume of plasma cleared of the drug by the kidneys over time) was calculated as: CLr = Ae/ AUClast, where Ae is the cumulative amount of analyte excreted in urine over the sampling interval.
Measured: Pre-dose and each time the participant voids up to 720 minutes post dose
Renal Clearance of Iohexol
Urine samples were collected pre-dose (time 0) and 5 mL urine samples were collected each time the subject voided. The total volume of urine excreted was recorded until 12 hours post-dose, and was analyzed using validated analytical methods. Renal clearance (the volume of plasma cleared of the drug by the kidneys over time) was calculated as: CLr = Ae/ AUClast, where Ae is the cumulative amount of analyte excreted in urine over the sampling interval.
Measured: Pre-dose and each time the participant voids up to 720 minutes post dose
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Quantum Leap Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase
Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the QuantumLeap device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the QuantumLeap device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.
Measured: Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Radiance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase
Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and will be analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the Radiance device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the Radiance device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.
Measured: Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With Normal-CKD Stage 2 Renal Function
Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, and 480 minutes post dose, and were analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the Brilliance device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the Brilliance device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.
Measured: Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, and 480 minutes post dose
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With CKD Stage 3-4 Renal Function
Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) and 960, 1440, 1920, 2400, and 2880 (±30 min) minutes post dose, and were analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the Brilliance device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the Brilliance device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.
Measured: Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) and 960, 1440, 1920, 2400, and 2880 (±30 min) minutes post dose
Number of Participants With Adverse Events Related to the Use of the QuantumLeap Device
The number of participants with adverse events related to the use of the QuantumLeap device was documented.
Measured: From the time of dosing through the follow-up visit, up to 10 days
Number of Participants With Adverse Events Related to the Use of the Radiance Device
The number of participants with adverse events related to the use of the Radiance device was documented.
Measured: From the time of dosing through the follow-up visit, up to 10 days
Number of Participants With Adverse Events Related to the Use of the Brilliance Device
The number of participants with adverse events related to the use of the Brilliance device was documented.
Measured: From the time of dosing through the follow-up visit, up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study start11 May 2016
- Primary completion4 Aug 2021
- Study completion4 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediBeacon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard B Dorshow, PhD, Study director, MediBeacon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772276
- Sponsor's protocol ID
- ORFM-2
- Status last verified
- Oct 2023
- First submitted
- 10 May 2016
- Last updated
- 26 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Dorshow RB, Debreczeny MP, Goldstein SL. GFR Measurement Using Transdermal Detection Methodology. J Am Soc Nephrol. 2025 Feb 7;36(8):1592-1602. doi: 10.1681/ASN.0000000639.
PubMed 39918882
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Safety and Pharmacokinetic Study of MB-102 Versus Iohexol and the Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types
- ClinicalTrials.gov ID
- NCT02772276
- Acronym / sponsor ID
- ORFM-2
- Conditions
- Acute Kidney Injury
- Keywords
- Glomerular Filtration Rate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- MediBeaconIndustry (pharma, biotech, devices)
- Study start
- 11 May 2016 (actual)
- Primary completion
- 4 Aug 2021 (actual)
- Study completion
- 4 Aug 2021 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Posted 26 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was a pilot, safety, and pharmacokinetic study of MB-102 versus iohexol and the use of the non-invasive optical renal function monitor (ORFM) device in normal and compromised renal function participants with different skin color types.
Detailed description
The objectives of this study were to evaluate the safety and tolerability of single and multiple doses of MB-102 in participants with normal and impaired kidney function; to determine plasma pharmacokinetics of MB-102 compared to the pharmacokinetics of iohexol in participants with normal and impaired kidney function; to demonstrate that MB-102-transdermal-fluorescence-measured glomerular filtration rate (GFR) using the optical renal function monitor (ORFM) Brilliance device is aligned with MB-102 plasma GFR; to evaluate the safety and effectiveness of the ORFM investigational medical device prototypes QuantumLeap, Radiance, and Brilliance for the non-invasive transdermal fluorescent detection of MB-102 in participants with a range of skin color types; and to determine the optimal dose of MB-102 for non-invasive measurement.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Normal-CKD Stage 2/QuantumLeap | Experimental | Drug: MB-102-- single dose of 4 µmol/kg, Drug: Iohexol, Device: QuantumLeapMB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses. |
| CKD Stage 3-4/QuantumLeap | Experimental | Drug: MB-102-- single dose of 4 µmol/kg, Drug: Iohexol, Device: QuantumLeapMB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses. |
| Normal-CKD Stage 2/Radiance | Experimental | Drug: MB-102-- single dose of 4 µmol/kg, Drug: Iohexol, Device: RadianceMB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Radiance ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. |
| CKD Stage 3-5/Radiance | Experimental | Drug: MB-102-- single dose of 4 µmol/kg, Drug: Iohexol, Device: RadianceMB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Radiance ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. |
| Normal-CKD Stage 2/Brilliance algorithm optimization | Experimental | Drug: MB-102-- single dose of 4 µmol/kg, Device: Brilliance (1 or 2 sensors)MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Algorithm optimization of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. |
| CKD Stage 3-5/Brilliance algorithm optimization | Experimental | Drug: MB-102-- single dose of 4 µmol/kg, Device: Brilliance (1 or 2 sensors)MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. Algorithm optimization of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. |
| Normal-CKD Stage 2/Brilliance sensor optimization | Experimental | Drug: MB-102-- single dose of 4 µmol/kg, Device: Brilliance (1 or 2 sensors)MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Sensor optimization of the Brilliance device was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. |
| Normal-CKD Stage 2/Brilliance sensor validation | Experimental | Drug: MB-102-- single dose of 4 µmol/kg, Device: Brilliance (1 or 2 sensors)MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Validation of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. |
| CKD Stage 3-5/Brilliance sensor validation | Experimental | Drug: MB-102-- single dose of 130 mg, Device: Brilliance (1 or 2 sensors)MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. Validation of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. |
| Normal-CKD Stage 2/Brilliance (1-2 sensors) | Experimental | Drug: MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart, Device: Brilliance (1 or 2 sensors)MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. A subset of participants in this arm received two doses of MB-102, 12 hours apart. |
| Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor) | Experimental | Drug: MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart, Device: Brilliance (1 or 2 sensors), Device: Brilliance (2-part sensor)MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors and 2-part sensor). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. A subset of participants in this arm received two doses of MB-102, 12 hours apart. |
| Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor) and 2 doses MB-102 | Experimental | Drug: MB-102-- two doses of 130 mg 24 hours apart, Device: Brilliance (1 or 2 sensors), Device: Brilliance (2-part sensor)Two doses of MB-102 administered to participants 12 hours apart, with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors and 2-part sensor). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. |
| CKD Stage 3-5/Brilliance 1-2 sensors | Experimental | Drug: MB-102-- single dose of 130 mg, Device: Brilliance (1 or 2 sensors)MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Main Criteria for Inclusion (Quantum Leap and Radiance device)
- Age > 22 years - male or female
- Participants willing to comply with study requirements
- Participants who have signed an informed consent form
- Normal or non-clinically significant screening and baseline 12-lead electrocardiogram (ECG) in the opinion of the principal investigator (PI)
Key exclusion criteria (75 listed)
- Main Criteria for Exclusion (QuantumLeap device)
- Women who are pregnant, lactating or planning to become pregnant during the study, or women who are of childbearing potential unwilling to use a barrier method of birth control
- Intolerant to venipuncture
- Recent donation or loss of blood or plasma: 100 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication
- Participation in another interventional trial within 30 days of screening or concurrently enrolled in any other medical research study which could impact the results of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MB-102-- single dose of 4 µmol/kgAlso: Relmapirazin4 µmol/kg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds. | Drug | CKD Stage 3-4/QuantumLeap, CKD Stage 3-5/Brilliance algorithm optimization, CKD Stage 3-5/Radiance, Normal-CKD Stage 2/Brilliance algorithm optimization, Normal-CKD Stage 2/Brilliance sensor optimization, Normal-CKD Stage 2/Brilliance sensor validation, Normal-CKD Stage 2/QuantumLeap, Normal-CKD Stage 2/Radiance |
| MB-102-- single dose of 130 mgAlso: Relmapirazin130 mg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds. A subset of participants will receive two doses of MB-102, 12 hours apart. | Drug | CKD Stage 3-5/Brilliance 1-2 sensors, CKD Stage 3-5/Brilliance sensor validation |
| MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apartAlso: Relmapirazin130 mg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds. | Drug | Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor), Normal-CKD Stage 2/Brilliance (1-2 sensors) |
| MB-102-- two doses of 130 mg 24 hours apartAlso: Relmapirazin4 µmol/kg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds. A subset of participants will receive two doses of MB-102, 12 hours apart. | Drug | Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor) and 2 doses MB-102 |
| IohexolAlso: Omnipaque 3005 mL of a 647 mg/mL solution administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds | Drug | CKD Stage 3-4/QuantumLeap, CKD Stage 3-5/Radiance, Normal-CKD Stage 2/QuantumLeap, Normal-CKD Stage 2/Radiance |
| QuantumLeapOptical Renal Function Monitor (ORFM) | Device | CKD Stage 3-4/QuantumLeap, Normal-CKD Stage 2/QuantumLeap |
| RadianceOptical Renal Function Monitor (ORFM) | Device | CKD Stage 3-5/Radiance, Normal-CKD Stage 2/Radiance |
| Brilliance (1 or 2 sensors)Optical Renal Function Monitor (ORFM) | Device | CKD Stage 3-5/Brilliance 1-2 sensors, CKD Stage 3-5/Brilliance algorithm optimization, CKD Stage 3-5/Brilliance sensor validation, Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor), Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor) and 2 doses MB-102, Normal-CKD Stage 2/Brilliance (1-2 sensors), Normal-CKD Stage 2/Brilliance algorithm optimization, Normal-CKD Stage 2/Brilliance sensor optimization, Normal-CKD Stage 2/Brilliance sensor validation |
| Brilliance (2-part sensor)Optical Renal Function Monitor (ORFM) | Device | Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor), Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor) and 2 doses MB-102 |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events
Time frame: From the time of dosing through the follow-up visit, up to 10 days
An adverse event is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, temporally associated with the use of a medicinal product, whether or not related to the investigational medical device or drug.
23 secondary outcomes
Maximum Plasma Concentration (Cmax) of MB-102
Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Maximum Plasma Concentration (Cmax) of Iohexol
Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Time to Maximum Plasma Concentration (Tmax) of MB-102
Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Time to Maximum Plasma Concentration (Tmax) of Iohexol
Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
The Elimination Half-life of MB-102
Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
The Elimination Half-life of Iohexol
Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102
Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Iohexol
Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102
Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Iohexol
Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Total Plasma Clearance of MB-102
Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Total Plasma Clearance of Iohexol
Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
The Terminal Rate Constant for MB-102
Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
The Terminal Rate Constant for Iohexol
Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Renal Clearance of MB-102
Time frame: Pre-dose and each time the participant voids up to 720 minutes post dose
Renal Clearance of Iohexol
Time frame: Pre-dose and each time the participant voids up to 720 minutes post dose
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Quantum Leap Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase
Time frame: Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Radiance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase
Time frame: Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With Normal-CKD Stage 2 Renal Function
Time frame: Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, and 480 minutes post dose
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With CKD Stage 3-4 Renal Function
Time frame: Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) and 960, 1440, 1920, 2400, and 2880 (±30 min) minutes post dose
Number of Participants With Adverse Events Related to the Use of the QuantumLeap Device
Time frame: From the time of dosing through the follow-up visit, up to 10 days
Number of Participants With Adverse Events Related to the Use of the Radiance Device
Time frame: From the time of dosing through the follow-up visit, up to 10 days
Number of Participants With Adverse Events Related to the Use of the Brilliance Device
Time frame: From the time of dosing through the follow-up visit, up to 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39918882Dorshow RB, Debreczeny MP, Goldstein SL. GFR Measurement Using Transdermal Detection Methodology. J Am Soc Nephrol. 2025 Feb 7;36(8):1592-1602. doi: 10.1681/ASN.0000000639.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard B Dorshow, PhD study director
MediBeacon, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MB-102-- single dose of 4 µmol/kg, MB-102-- single dose of 130 mg and MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart in people with Acute Kidney Injury, run by MediBeacon at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 75 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (time frame: From the time of dosing through the follow-up visit, up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02772276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.