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Diabetic Kidney DiseasePhase 2NCT01752985

Study to Evaluate the Effects of BMS-813160 on Protein Loss in the Urine of Subjects With Type 2 Diabetes and Diabetic Kidney Disease

A Phase 2 study testing BMS-813160 in people with Diabetic Kidney Disease, run by Bristol-Myers Squibb at 62 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine whether BMS-813160 will reduce the amount of protein loss in the urine of subjects with type 2 diabetes and diabetic kidney disease Read more about this study

Who is it for?
Any age
Conditions the study is for
Diabetic Kidney Disease
What is being tested?
BMS-813160
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
319 participants
Where
62 sitesin 4 countries
Study dates
18 Mar 2013to 30 Jun 2015
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Clinical diagnosis of type 2 diabetes mellitus with macroalbuminuria (UACR between 200 and 3500 mg/g)
  • Background angiotensin converting enzyme inhibitor (ACEI) or angiotensin-receptor blocker (ARB) therapy

Who cannot join

  • Clinical diagnosis of type 1 diabetes
  • Unstable cardiovascular, metabolic, or other chronic disease status
  • Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2
  • High risk of infection or immune compromise
  • Clinically significant ECG conduction abnormalities
  • Drugs with significant potential to affect BMS-813160 exposure

Trial locations and contacts

62 sites in 4 countries.

62 sites in 4 countries

United States43 sites

  • Albany Medical College

    Albany, New York, 12206

  • The Endocrine Group Llp

    Albany, New York, 12206

  • Emory University School Of Medicine

    Atlanta, Georgia, 30303

  • Uab Hospital

    Birmingham, Alabama, 35294

  • Univ Of Al At Birmingham

    Birmingham, Alabama, 35294

  • Medispect Medical Research, Llc

    Boone, North Carolina, 28607

  • Burke Internal Medicine And Research

    Burke, Virginia, 22015

  • Metrolina Internal Medicine

    Charlotte, North Carolina, 28204

  • Virginia Endocrinology Research

    Chesapeake, Virginia, 23321

  • John H. Stroger, Jr. Hospital Of Cook County

    Chicago, Illinois, 60612

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • All Medical Research, Llc

    Cooper City, Florida, 33024

  • Duke University

    Durham, North Carolina, 27705

  • Doctors Hospital At Renaissance

    Edinburg, Texas, 78539

  • Research By Design, Llc

    Evergreen Park, Illinois, 60805

  • Nephrology Associates

    Flushing, New York, 11355

  • San Antonio Military Medical Center

    Fort Sam Houston, Texas, 78234-6200

  • San Antonio Military Medical Center

    Fort Sam Houston, Texas, 78234

  • International Research Associates, Llc

    Hialeah, Florida, 33012

  • Piedmont Health Grp, Llc-Twr Pt Res Ctr

    Hodges, South Carolina, 29653

  • Academic Medical Research Institute

    Los Angeles, California, 90022

  • Ucla

    Los Angeles, California, 90025

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Paramount Medical Research & Consulting, Llc

    Middleburg Heights, Ohio, 44130

  • Southern Nh Diab And Endo

    Nashua, New Hampshire, 03063

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-1371

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Providence Clinical Research

    North Hollywood, California, 91606

  • Diabetes Medical Center Of California

    Northridge, California, 91325

  • Va Nebraska-Western Iowa Health Care System (Nwihcs)

    Omaha, Nebraska, 68105

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Akdhc Medical Research Services Llc

    Phoenix, Arizona, 85012

  • Mcguire Va Medical Center

    Richmond, Virginia, 23249

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia, 30076

  • Northeast Clinical Research Of San Antonio, Llc

    Schertz, Texas, 78154

  • St Louis Center Clinl Res

    St Louis, Missouri, 63128

  • St. Louis Center For Clinical Research

    St Louis, Missouri, 63128

  • Genesis Clinical Research, Inc.

    Tampa, Florida, 33614

  • Premier Research, Inc.

    Trenton, New Jersey, 08611

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Physician Research, Inc.

    Zanesville, Ohio, 43701

Other trials in United States

Canada9 sites

  • Aggarwal And Associates

    Brampton, Ontario, L6T 0G1

  • Clinical Research Solutions, Inc

    Kitchener, Ontario, N2H 5Z8

  • Centre De Recherche Clinique De Laval

    Laval, Quebec, H7T 2P5

  • Recherche Gcp Research

    Montreal, Quebec, H2R 1V6

  • Local Institution

    Montreal, Quebec, H3T 1E2

  • Eastern Health Sciences Center

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Lmc Diabetes & Endocrinology (Thornhill)

    Thornhill, Ontario, L4J 8L7

  • Lmc Diabetes & Endocrinology (Bayview)

    Toronto, Ontario, M4G 3E8

  • Health Sciences Centre Diabetes Research Centre

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

France6 sites

  • Local Institution

    Amiens, 80054

  • Local Institution

    Grenoble, F38043

  • Local Institution

    Nantes, 44093

  • Local Institution

    Paris, 75877

  • Local Institution

    Poitiers, 86021

  • Local Institution

    Tours, 37044

Other trials in France

Denmark4 sites

  • Local Institution

    Frederiksberg, 2000

  • Local Institution

    Gentofte Municipality, 2820

  • Local Institution

    Hillerød, 3400

  • Local Institution

    Holstebro, 7500

Other trials in Denmark

About this study

Official title: A Double-Blind, Placebo-Controlled, Randomized, Two-stage, Parallel-Group, Adaptive Design Phase 2a Study to Evaluate the Effects of BMS-813160 in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (DKD) Who Have Residual Macroalbuminuria Despite Treatment With an Inhibitor of the Renin-Angiotensin System

The purpose of this study is to determine whether BMS-813160 will reduce the amount of protein loss in the urine of subjects with type 2 diabetes and diabetic kidney disease

Being tested
BMS-813160, Placebo matching with BMS-813160
Medical subject headings
Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-813160Drug

  • Placebo matching with BMS-813160Drug

Study groups in NCT01752985
Study groupRoleWhat they receive
Arm A: BMS-813160 150 mg & Placebo matching with BMS-813160ExperimentalBMS-813160 150 mg capsules by mouth in AM and Placebo matching with BMS-813160 in PM for 12 weeks
Receives: Drug: BMS-813160; Drug: Placebo matching with BMS-813160
Arm B: BMS-813160 300 mgExperimentalBMS-813160 300 mg capsules by mouth twice daily for 12 weeks
Receives: Drug: BMS-813160
Arm C: Placebo matching with BMS-813160Placebo comparatorPlacebo matching with BMS-813160 0 mg capsules by mouth twice daily for 12 weeks
Receives: Drug: Placebo matching with BMS-813160

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment With BMS-813160

    The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples. UACR was calculated as the geometric mean of two first-morning void urine UACR measurements with samples collected on two separate occasions within a 4-day period.

    Measured: Baseline, Weeks 2, 4, 8, 12, and 16 (Follow-up)

Secondary outcomes (6)

  1. Number of Participants With Serious Adverse Events (SAEs), Who Died and With Other (Not Including Serious) Adverse Events

    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event.

    Measured: From the date of subject's written consent until 30 days post discontinuation of dosing, assessed up to 26 months

  2. Number of Participants With Out-of-Range Electrocardiogram (ECG) Interval

    12-lead ECGs were performed before and 1 hour after dosing at Weeks 0, 2 and 4. ECGs were recorded after the participant has been supine for at least 5 minutes. The PR interval was defined as the beginning of the P wave to the beginning of the QRS complex, and represents the time taken by electrical impulse to travel from the sinus node through the atrioventricular (AV) node. The QRS complex represented the rapid depolarization of the right and left ventricles. The QT interval was defined as the time from the start of the Q wave to the end of the T wave, and represents the time taken for ventricular depolarization and repolarization. Participants were evaluated for abnormal ECG intervals. Criteria's for abnormality were PR >200, QRS >120, QT >500, QTcF >450, Change From Baseline >30 milliseconds (msec).

    Measured: Baseline up to Week 16

  3. Trough Observed Plasma Concentration (Ctrough) of BMS-813160

    Ctrough is the minimum estimated plasma concentration at steady state.

    Measured: Pre-dose at Week 2, 4, 8, 12 and 0.5, 1, 2, 4, and 6 hours post-dose at Week 12

  4. Area Under The Plasma Concentration-Time Curve From Time Zero to 6 Hours Post-Dose [AUC(0-6 h)]

    AUC(0-6 h) is the area under the plasma concentration-time curve from pre-dose (0 h) to 6 h post-dose.

    Measured: Pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose at Week 12

  5. Renal Clearance (CLr) of BMS-813160

    CLr was calculated by dividing the total amount excreted in the urine from 0 to 6 hours by the area under the plasma concentration-time curve from time zero extrapolated to infinite time. The renal function was classified based on estimated glomerular filtration rate as normal (>=90 mL/min/1.73 m^2), mildly impaired (60-89 mL/min/1.73 m^2), moderately impaired stage 3A (45-59 mL/min/1.73 m^2), and moderately impaired stage 3B (30-44 L/min/1.73 m^2).

    Measured: Pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose at Week 12

  6. Dose-Response Relationship Using Change in Baseline Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment

    The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples. UACR was calculated as the geometric mean of two first-morning void urine UACR measurements with samples collected on two separate occasions within a 4-day period. The effect of BMS-813160 on urinary albumin excretion as measured by UACR values in participants with diabetic kidney disease after 12 weeks of treatment was assessed. The model included treatment group as a main effect, and the log of baseline UACR values, as well as baseline values of eGFR, blood pressure, blood glucose and lipid levels, as covariates.

    Measured: Baseline, Weeks 2, 4, 8 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2012 (estimated)
  2. Study start18 Mar 2013
  3. Primary completion30 Jun 2015
  4. Study completion30 Jun 2015

Why it stopped: Business objectives have changed

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
319 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01752985
Sponsor's protocol ID
CV202-010
Other IDs
2012-005093-54
Status last verified
Jul 2019
First submitted
17 Dec 2012
Last updated
30 Jul 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-813160 in people with Diabetic Kidney Disease, run by Bristol-Myers Squibb at 62 sites in 4 countries.

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 2 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: stopped early, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Canada, France, Denmark. 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 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 25 Jun 2019). 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?

Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment With BMS-813160 (time frame: Baseline, Weeks 2, 4, 8, 12, and 16 (Follow-up)). 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 NCT01752985.

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 30 Jul 2019.

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