Type 2 Diabetics, Chronic Kidney Disease, Protein in UrinePhase 1NCT01464320
A Study to Evaluate the Safety and Tolerability of ABT-614 and Its Effect on Kidney Function in Subjects With Type 2 Diabetes and Chronic Kidney Disease With Protein in Their Urine.
A Phase 1 study testing ABT-614 in people with Type 2 Diabetics, Chronic Kidney Disease, Protein in Urine, run by Abbott at 1 site in United States.
Trial summary
To assess the safety, tolerability and pharmacokinetics of ABT-614 in subjects with type 2 diabetes and chronic kidney disease with albuminuria and to determine whether ABT-614 reduces glomerular filtration rate. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Type 2 Diabetics, Chronic Kidney Disease, Protein in Urine
- What is being tested?
- ABT-614
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Apr 2012
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged between 19 and 70 years, inclusive, at time of consent.
- Type 2 diabetes receiving at least one anti-diabetic medication for at least one year at the time of Screening.
- Hemoglobin A1c < 12% at the time of Screening.
- Estimated glomerular filtration rate ≥ 30 mL/min calculated by the Cockcroft-Gault Formula at the time of Screening.
- Urinary albumin to creatinine ratio 100 to 5000 mg/g creatinine at the time of Screening.
Who cannot join
- History of unusual or allergic reaction to iodine, to products containing iodine (for example., iodine containing foods) or to other radio-opaque agents.
- Subject history of epileptic seizures or convulsions.
- Clinically significant cardiac disease or family history of long-QT syndrome and/or subject and/or family history of unexplained, sudden cardiac death. History of myocardial infarction or coronary artery bypass graft is not exclusionary if occurrence is ≥ 12 months prior to the administration of study drug and the subject does not have conduction abnormality and has been stable without intervention, symptoms of ischemia or an increase in cardiovascular medications. Electrocardiography (ECG) should be compared with historical to ensure no new clinically significant changes have occurred.
- History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, potential hydrogen (pH) or absorption.
- Clinically significant respiratory (except mild asthma), gastrointestinal, hematologic, neurologic, thyroid or any uncontrolled medical illness or psychiatric disease or disorder.
- Screening ECG with clinically significant abnormalities and/or confirmed Screening QTcF prolongation more than 430 milliseconds for males and 450 milliseconds for females or ECG with second or third degree atrioventricular block.
Trial locations and contacts
1 site in 1 country.
United States1 site
Site Reference ID/Investigator# 63442
Miami, Florida, 33136
About this study
Official title: A Phase 1b, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Single-Dose of ABT-614 and the Effect of ABT-614 on Glomerular Filtration Rate in Subjects With Type 2 Diabetes and Chronic Kidney Disease With Albuminuria
To assess the safety, tolerability and pharmacokinetics of ABT-614 in subjects with type 2 diabetes and chronic kidney disease with albuminuria and to determine whether ABT-614 reduces glomerular filtration rate.
Read the detailed description
This Phase 1b, single-site, double-blind, randomized, placebo-controlled study will be conducted in three Periods; Baseline, Dosing and Outpatient. Eligible adult male and female subjects with type 2 diabetes and CKD (chronic kidney disease) with albuminuria will be selected to participate.
Eighteen subjects will be selected to participate in the Baseline Period to ensure that 16 subjects are enrolled in the Dosing Period. Subjects who are eligible from Screening will be confined to the study site beginning on Day -2 (the day before the Baseline Period infusion). On Day -1, subjects will be administered an iothalamate infusion to measure baseline GFR (glomerular filtration rate). Subjects who continue to be eligible on Day 1 will be randomized in a 1:1 ratio to receive either a 10 mg dose of ABT-614 or matching placebo daily, for 15 days.
On Day 15 subjects will be administered a second iothalamate infusion. Plasma and urine samples for ABT-614 and iothalamate will be collected. Subjects will be released from confinement on Day 20 after the completion of all study procedures including the 120-hour blood sample collection. Thereafter, subjects will return for outpatient visits on Days 25 and 30 as well as 30 days after the last dose of study drug. A ± 2 day window will be permitted on the 30-day Follow-up Visit to accommodate subject scheduling.
- Being tested
- ABT-614, Placebo Comparator
- Keywords
- Safety, Type 2 diabetes, Kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Proteinuria, Diabetes Mellitus, Type 2, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-614Drug
Active
Placebo ComparatorDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| ABT-614 | Experimental | Not described Receives: Drug: ABT-614 |
| Placebo Comparator | Placebo comparator | Not described Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in drug concentration
Blood and urine tests
Measured: Day -1 (Baseline) and up to Day 15
Change in glomerular filtration rate
Blood and urine tests
Measured: Day -1 (Baseline) and up to Day 15
Secondary outcomes (1)
Change in urinary albumin excretion
Urine tests
Measured: Day -1 (Baseline) and up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetics, Chronic Kidney Disease, Protein in UrineStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis Andress, MD, Study director, Renal Global Project Team, Abbott Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464320
- Sponsor's protocol ID
- M13-107
- Status last verified
- Apr 2012
- First submitted
- 1 Nov 2011
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Single-Dose of ABT-614 and the Effect of ABT-614 on Glomerular Filtration Rate in Subjects With Type 2 Diabetes and Chronic Kidney Disease With Albuminuria
- ClinicalTrials.gov ID
- NCT01464320
- Acronym / sponsor ID
- M13-107
- Keywords
- Safety, Type 2 diabetes, Kidney disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 3 Nov 2011 (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.
To assess the safety, tolerability and pharmacokinetics of ABT-614 in subjects with type 2 diabetes and chronic kidney disease with albuminuria and to determine whether ABT-614 reduces glomerular filtration rate.
Detailed description
This Phase 1b, single-site, double-blind, randomized, placebo-controlled study will be conducted in three Periods; Baseline, Dosing and Outpatient. Eligible adult male and female subjects with type 2 diabetes and CKD (chronic kidney disease) with albuminuria will be selected to participate.
Eighteen subjects will be selected to participate in the Baseline Period to ensure that 16 subjects are enrolled in the Dosing Period. Subjects who are eligible from Screening will be confined to the study site beginning on Day -2 (the day before the Baseline Period infusion). On Day -1, subjects will be administered an iothalamate infusion to measure baseline GFR (glomerular filtration rate). Subjects who continue to be eligible on Day 1 will be randomized in a 1:1 ratio to receive either a 10 mg dose of ABT-614 or matching placebo daily, for 15 days.
On Day 15 subjects will be administered a second iothalamate infusion. Plasma and urine samples for ABT-614 and iothalamate will be collected. Subjects will be released from confinement on Day 20 after the completion of all study procedures including the 120-hour blood sample collection. Thereafter, subjects will return for outpatient visits on Days 25 and 30 as well as 30 days after the last dose of study drug. A ± 2 day window will be permitted on the 30-day Follow-up Visit to accommodate subject scheduling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABT-614 | Experimental | Drug: ABT-614 |
| Placebo Comparator | Placebo comparator | Drug: Placebo Comparator |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged between 19 and 70 years, inclusive, at time of consent.
- Type 2 diabetes receiving at least one anti-diabetic medication for at least one year at the time of Screening.
- Hemoglobin A1c < 12% at the time of Screening.
- Estimated glomerular filtration rate ≥ 30 mL/min calculated by the Cockcroft-Gault Formula at the time of Screening.
- Urinary albumin to creatinine ratio 100 to 5000 mg/g creatinine at the time of Screening.
Key exclusion criteria (6 listed)
- History of unusual or allergic reaction to iodine, to products containing iodine (for example., iodine containing foods) or to other radio-opaque agents.
- Subject history of epileptic seizures or convulsions.
- Clinically significant cardiac disease or family history of long-QT syndrome and/or subject and/or family history of unexplained, sudden cardiac death. History of myocardial infarction or coronary artery bypass graft is not exclusionary if occurrence is ≥ 12 months prior to the administration of study drug and the subject does not have conduction abnormality and has been stable without intervention, symptoms of ischemia or an increase in cardiovascular medications. Electrocardiography (ECG) should be compared with historical to ensure no new clinically significant changes have occurred.
- History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, potential hydrogen (pH) or absorption.
- Clinically significant respiratory (except mild asthma), gastrointestinal, hematologic, neurologic, thyroid or any uncontrolled medical illness or psychiatric disease or disorder.
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 |
|---|---|---|
| ABT-614Active | Drug | ABT-614 |
| Placebo ComparatorPlacebo | Drug | Placebo Comparator |
Primary outcome
Change in drug concentration
Time frame: Day -1 (Baseline) and up to Day 15
Blood and urine tests
Change in glomerular filtration rate
Time frame: Day -1 (Baseline) and up to Day 15
Blood and urine tests
1 secondary outcome
Change in urinary albumin excretion
Time frame: Day -1 (Baseline) and up to Day 15
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 22 Aug 2012.
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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.
Dennis Andress, MD study director
Renal Global Project Team, Abbott Laboratories
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 ABT-614 in people with Type 2 Diabetics, Chronic Kidney Disease, Protein in Urine, run by Abbott 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 5 inclusion and 6 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 22 Aug 2012. 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. Some participants in this study may receive a placebo. 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?
Change in drug concentration (time frame: Day -1 (Baseline) and up to Day 15). The study lists 2 primary outcomes in all. 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 22 Aug 2012.