Renal Insufficiency, ChronicPhase 1NCT02437422
Study to Assess the Safety and Impact on Humoral Sensitization of SANGUINATE in Patients With End Stage Renal Disease
A Phase 1 study testing SANGUINATE in people with Renal Insufficiency, Chronic, run by Prolong Pharmaceuticals at 1 site in United States.
Trial summary
A Phase Ib, Open-Label, Single Arm Study to Assess the Safety, Pharmacokinetics, and Impact on Humoral Sensitization of SANGUINATE Infusion in Patients with End Stage Renal Disease (ESRD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- SANGUINATE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2015to 18 Nov 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient diagnosed with End State Renal Disease requiring renal replacement therapy.
- Age 18 - 65 years of age who are on maintenance hemodialysis for at least 3 months prior to the study start;
- Stable dialysis treatment regimen 3 times per week for ≥ 2 months prior to screening visit;
- Hemoglobin >7.5 g/dL with or without clinical symptoms;
- Women of childbearing potential must have a negative serum pregnancy test and must use a reliable method of contraception during the study period;
- Signed and dated informed written consent by the subject or his/her legally authorized representative;
Who cannot join
- In the judgment of the investigator the patient is not a good candidate for the study;
- Blood transfusion with in the last 90 days from date of Screening;
- Symptoms or electrocardiogram (ECG)-based signs of acute myocardial infarction, Unstable angina pectoris, decompensated heart failure, third degree heart block or cardiac arrhythmia associated with hemodynamic instability;
- Total bilirubin greater than 1.5 mg/dL or transaminase (ALT, AST) elevations greater than 2 times the upper limit of the laboratory reference range or evidence of significant hepatic insufficiency;
- Concurrent or prior treatment within 90 days of Screening with an investigational medication;
- Chronic treatment (as determined by the Investigator) with any immunosuppressive medication (including corticosteroids) within the past 90 days of Screening;
Show all 11Show fewer
- Evidence or history of regular alcohol abuse;
- Screening laboratory result(s) determined to be clinically significant by the investigator;
- Screening laboratory result indicating HIV-positivity, or previously diagnosed with AIDS, AIDS related complex or any other immunodeficiency;
- Screening laboratory result or laboratory results performed within one year indicating positivity for hepatitis B surface antigens, hepatitis B core antibodies, or hepatitis C antibodies;
- Uncontrolled Diabetes Mellitus (Patients with HbA1c > 9% at screening)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati/ Division of Nephrology
Cincinnati, Ohio, 45267-0585
About this study
Official title: A Phase Ib, Open-Label, Single Arm Study to Assess the Safety, Pharmacokinetics, and Impact on Humoral Sensitization of SANGUINATE Infusion in Patients With End-Stage Renal Disease (ESRD)
A Phase Ib, Open-Label, Single Arm Study to Assess the Safety, Pharmacokinetics, and Impact on Humoral Sensitization of SANGUINATE Infusion in Patients with End Stage Renal Disease (ESRD).
Read the detailed description
The purpose of the study is to investigate the safety of SANGUINATE on humoral sensitization in End Stage Renal Disease (ESRD) patients receiving dialysis.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- SANGUINATE
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SANGUINATEBiological
Also called (pegylated carboxyhemoglobin bovine)
Single two-hour infusion of SANGUINATE
| Study group | Role | What they receive |
|---|---|---|
| SANGUINATE | Experimental | Single infusion of SANGUINATE Receives: Biological: SANGUINATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of study treatment as determined by changes in vital signs, electrocardiographic assessments, clinical signs, and bio-analytical measures (e.g., blood chemistry, hematology), and reported adverse events following infusion
Composite endpoint with multiple vital signs, ECGs, clinical assessments and bio-analytical lab measurements over the 90 day time frame.
Measured: 90 days
Secondary outcomes (7)
Mean change in the number of HLA-Antibody specificities determined by single antigen bead assays
Antibody testing Human leukocyte antigen- antibody (HLA-Ab) HLA Tissue Typing (screening visit only) Calculated Panel Reactive Antibody (CPRA)
Measured: 90 days
Mean change in the overall strength of HLA-Antibody specificities determined by single antigen bead assays
Antibody testing Human leukocyte antigen- antibody (HLA-Ab) HLA Tissue Typing (screening visit only) Calculated Panel Reactive Antibody (CPRA)
Measured: 90 days
Mean change in the calculated panel reactive antibody (CPRA)
Antibody testing
Measured: 90 days
Percent of patients with an increase in number of HLA-Ab specificities determined by single antigen bead assays
Antibody testing
Measured: 90 Days
Percent of patients with an increase in CPRA
Antibody testing
Measured: 90 Days
Pharmacokinetic profile as determined from blood plasma over time (Tmax, Cmax, AUC, half-life, coefficient of variation, and the apparent elimination rate constant)
Measured: 22 Days
Percent of patients with an increase in the overall strength of HLA-Antibodies
Antibody testing
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study start5 Jun 2015
- Primary completion18 Nov 2015
- Study completion18 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prolong Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bassam G Abu Jadweh, MD, Principal investigator, University of Cincinnati/ Division of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437422
- Sponsor's protocol ID
- SGTP-001
- Status last verified
- May 2018
- First submitted
- 6 Apr 2015
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-Label, Single Arm Study to Assess the Safety, Pharmacokinetics, and Impact on Humoral Sensitization of SANGUINATE Infusion in Patients With End-Stage Renal Disease (ESRD)
- ClinicalTrials.gov ID
- NCT02437422
- Acronym / sponsor ID
- SGTP-001
- Conditions
- Renal Insufficiency, Chronic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Prolong PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2015 (actual)
- Primary completion
- 18 Nov 2015 (actual)
- Study completion
- 18 Nov 2015 (actual)
- First posted
- 7 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase Ib, Open-Label, Single Arm Study to Assess the Safety, Pharmacokinetics, and Impact on Humoral Sensitization of SANGUINATE Infusion in Patients with End Stage Renal Disease (ESRD).
Detailed description
The purpose of the study is to investigate the safety of SANGUINATE on humoral sensitization in End Stage Renal Disease (ESRD) patients receiving dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SANGUINATE | Experimental | Biological: SANGUINATESingle infusion of SANGUINATE |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient diagnosed with End State Renal Disease requiring renal replacement therapy.
- Age 18 - 65 years of age who are on maintenance hemodialysis for at least 3 months prior to the study start;
- Stable dialysis treatment regimen 3 times per week for ≥ 2 months prior to screening visit;
- Hemoglobin >7.5 g/dL with or without clinical symptoms;
- Women of childbearing potential must have a negative serum pregnancy test and must use a reliable method of contraception during the study period;
Key exclusion criteria (11 listed)
- In the judgment of the investigator the patient is not a good candidate for the study;
- Blood transfusion with in the last 90 days from date of Screening;
- Symptoms or electrocardiogram (ECG)-based signs of acute myocardial infarction, Unstable angina pectoris, decompensated heart failure, third degree heart block or cardiac arrhythmia associated with hemodynamic instability;
- Total bilirubin greater than 1.5 mg/dL or transaminase (ALT, AST) elevations greater than 2 times the upper limit of the laboratory reference range or evidence of significant hepatic insufficiency;
- Concurrent or prior treatment within 90 days of Screening with an investigational medication;
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 |
|---|---|---|
| SANGUINATEAlso: (pegylated carboxyhemoglobin bovine)Single two-hour infusion of SANGUINATE | Biological | SANGUINATE |
Primary outcome
Safety of study treatment as determined by changes in vital signs, electrocardiographic assessments, clinical signs, and bio-analytical measures (e.g., blood chemistry, hematology), and reported adverse events following infusion
Time frame: 90 days
Composite endpoint with multiple vital signs, ECGs, clinical assessments and bio-analytical lab measurements over the 90 day time frame.
7 secondary outcomes
Mean change in the number of HLA-Antibody specificities determined by single antigen bead assays
Time frame: 90 days
Mean change in the overall strength of HLA-Antibody specificities determined by single antigen bead assays
Time frame: 90 days
Mean change in the calculated panel reactive antibody (CPRA)
Time frame: 90 days
Percent of patients with an increase in number of HLA-Ab specificities determined by single antigen bead assays
Time frame: 90 Days
Percent of patients with an increase in CPRA
Time frame: 90 Days
Pharmacokinetic profile as determined from blood plasma over time (Tmax, Cmax, AUC, half-life, coefficient of variation, and the apparent elimination rate constant)
Time frame: 22 Days
Percent of patients with an increase in the overall strength of HLA-Antibodies
Time frame: 90 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
Related trials for Renal Insufficiency, Chronic
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Bassam G Abu Jadweh, MD principal investigator
University of Cincinnati/ Division of Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SANGUINATE in people with Renal Insufficiency, Chronic, run by Prolong Pharmaceuticals at 1 site 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 6 inclusion and 11 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 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety of study treatment as determined by changes in vital signs, electrocardiographic assessments, clinical signs, and bio-analytical measures (e.g., blood chemistry, hematology), and reported adverse events following infusion (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2018.