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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01752985
First received: December 17, 2012
Last updated: April 17, 2015
Last verified: April 2015
  Purpose

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


Condition Intervention Phase
Diabetic Kidney Disease
Drug: BMS-813160
Drug: Placebo matching with BMS-813160
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Percent change from baseline (Day -4 to Day -1) in Urinary Albumin-to-Creatinine Ratio (UACR) across 12 weeks of treatment with BMS-813160 [ Time Frame: Baseline (up to Day -1) ] [ Designated as safety issue: No ]
  • Percent change from baseline (Day -4 to Day -1) in UACR across 12 weeks of treatment with BMS-813160 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Percent change from baseline (Day -4 to Day -1) in UACR across 12 weeks of treatment with BMS-813160 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Percent change from baseline (Day -4 to Day -1) in UACR across 12 weeks of treatment with BMS-813160 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Percent change from baseline (Day -4 to Day -1) in UACR across 12 weeks of treatment with BMS-813160 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trough observed plasma concentration (Ctrough) of BMS-813160 [ Time Frame: Baseline (up to Day -1), weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Exposure-response relationship between the geometric mean of measured BMS-813160 Ctrough values during the 12-week treatment period and percent change from baseline (Day -4 to Day -1) in UACR

  • Renal Clearance (CLr) of BMS-813160 [ Time Frame: Baseline (up to Day -1), week 12 only from 0-6 h post dose ] [ Designated as safety issue: No ]
    Exposure-response relationship between the geometric mean of measured BMS-813160 Ctrough values during the 12-week treatment period and percent change from baseline (Day -4 to Day -1) in UACR

  • Percent change from baseline (Day -4 to Day -1) in UACR during the 12-week treatment [ Time Frame: Baseline (up to Day -1), weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]

    Exposure-response relationship between the geometric mean of measured BMS-813160 Ctrough values during the 12-week treatment period and percent change from baseline (Day -4 to Day -1) in UACR

    Dose-response relationship between BMS-813160 dose and percent change from baseline (Day -4 to Day -1) in UACR during the 12-week treatment period


  • Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs), physical examinations, and clinical laboratory tests [ Time Frame: Upto week 16 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: April 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: BMS-813160 150 mg & Placebo matching with BMS-813160
BMS-813160 150 mg capsules by mouth in AM and Placebo matching with BMS-813160 in PM for 12 weeks
Drug: BMS-813160 Drug: Placebo matching with BMS-813160
Experimental: Arm B: BMS-813160 300 mg
BMS-813160 300 mg capsules by mouth twice daily for 12 weeks
Drug: BMS-813160
Placebo Comparator: Arm C: Placebo matching with BMS-813160
Placebo matching with BMS-813160 0 mg capsules by mouth twice daily for 12 weeks
Drug: Placebo matching with BMS-813160

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752985

  Hide Study Locations
Locations
United States, Alabama
Univ Of Al At Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Akdhc Medical Research Services Llc
Phoenix, Arizona, United States, 85012
United States, California
Academic Medical Research Institute
Los Angeles, California, United States, 90022
Ucla
Los Angeles, California, United States, 90025
Providence Clinical Research
North Hollywood, California, United States, 91606
Diabetes Medical Center Of California
Northridge, California, United States, 91325
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
United States, District of Columbia
George Washington University Medical Faculty Associates
Washington, District of Columbia, United States, 20037
United States, Florida
All Medical Research, Llc
Cooper City, Florida, United States, 33024
International Research Associates, Llc
Hialeah, Florida, United States, 33012
Genesis Clinical Research, Inc.
Tampa, Florida, United States, 33614
United States, Georgia
Emory University School Of Medicine
Atlanta, Georgia, United States, 30303
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States, 30076
United States, Illinois
John H. Stroger, Jr. Hospital Of Cook County
Chicago, Illinois, United States, 60612
Research By Design, Llc
Evergreen Park, Illinois, United States, 60805
United States, Missouri
St Louis Center Clinl Res
Saint Louis, Missouri, United States, 63128
United States, Nebraska
Va Nebraska-Western Iowa Health Care System (Nwihcs)
Omaha, Nebraska, United States, 68105
United States, New Hampshire
Southern Nh Diab And Endo
Nashua, New Hampshire, United States, 03063
United States, New Jersey
Premier Research, Inc.
Trenton, New Jersey, United States, 08611
United States, New York
The Endocrine Group Llp
Albany, New York, United States, 12206
Nephrology Associates
Flushing, New York, United States, 11355
United States, North Carolina
Medispect Medical Research, Llc
Boone, North Carolina, United States, 28607
Metrolina Internal Medicine
Charlotte, North Carolina, United States, 28204
Duke University
Durham, North Carolina, United States, 27705
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Paramount Medical Research & Consulting, Llc
Middleburg Heights, Ohio, United States, 44130
Physician Research, Inc.
Zanesville, Ohio, United States, 43701
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Piedmont Health Grp, Llc-Twr Pt Res Ctr
Hodges, South Carolina, United States, 29653
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Doctors Hospital At Renaissance
Edinburg, Texas, United States, 78539
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States, 78234
Northeast Clinical Research Of San Antonio, Llc
Schertz, Texas, United States, 78154
United States, Virginia
Burke Internal Medicine And Research
Burke, Virginia, United States, 22015
Virginia Endocrinology Research
Chesapeake, Virginia, United States, 23321
Manassas Clinical Research Center
Manassas, Virginia, United States, 20110
Mcguire Va Medical Center
Richmond, Virginia, United States, 23249
Canada, Manitoba
Health Sciences Centre Diabetes Research Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Newfoundland and Labrador
Eastern Health Sciences Center
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Aggarwal And Associates
Brampton, Ontario, Canada, L6T 0G1
Clinical Research Solutions, Inc
Kitchener, Ontario, Canada, N2H 5Z8
Lmc Diabetes & Endocrinology (Thornhill)
Thornhill, Ontario, Canada, L4J 8L7
Lmc Diabetes & Endocrinology (Bayview)
Toronto, Ontario, Canada, M4G 3E8
Canada, Quebec
Centre De Recherche Clinique De Laval
Laval, Quebec, Canada, H7T 2P5
Local Institution
Montreal, Quebec, Canada, H3T 1E2
Recherche Gcp Research
Montreal, Quebec, Canada, H2R 1V6
Denmark
Local Institution
Frederiksberg, Denmark, 2000
Local Institution
Gentofte, Denmark, 2820
Local Institution
Hillerod, Denmark, 3400
Local Institution
Holstebro, Denmark, 7500
France
Local Institution
Amiens Cedex 1, France, 80054
Local Institution
Grenoble Cedex 9, France, F38043
Local Institution
Nantes Cedex 1, France, 44093
Local Institution
Paris, France, 75877
Local Institution
Poitiers Cedex, France, 86021
Local Institution
Tours Cedex 09, France, 37044
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01752985     History of Changes
Other Study ID Numbers: CV202-010, 2012-005093-54
Study First Received: December 17, 2012
Last Updated: April 17, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 23, 2015