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 currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01752985
First received: December 17, 2012
Last updated: September 22, 2014
Last verified: August 2014
  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: March 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (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

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Hide Study Locations
Locations
United States, Alabama
Univ Of Al At Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Dana Rizk, Site 0023    205-934-9509      
United States, Arizona
Local Institution Not yet recruiting
Phoenix, Arizona, United States, 85012
Contact: Site 0074         
United States, California
Ucla Recruiting
Los Angeles, California, United States, 90025
Contact: Anjay Rastogi, Site 0034    310-206-6741      
Local Institution Not yet recruiting
Los Angeles, California, United States, 90022
Contact: Site 0078         
Providence Clinical Research Recruiting
North Hollywood, California, United States, 91606
Contact: Teresa Sligh, Site 0021    818-558-7555      
Diabetes Medical Center Of California Recruiting
Northridge, California, United States, 91325
Contact: Gholamreza Bonabi, Site 0018    818-368-4212      
Diablo Clinical Research, Inc. Terminated
Walnut Creek, California, United States, 94598
United States, District of Columbia
George Washington University Medical Faculty Associates Recruiting
Washington, District of Columbia, United States, 20037
Contact: Susie Lew, Site 0043    202-741-2283      
United States, Florida
All Medical Research, Llc Recruiting
Cooper City, Florida, United States, 33024
Contact: Lorena Lewy-Alterbaum, Site 0010    754-263-2000      
International Research Associates, Llc Recruiting
Hialeah, Florida, United States, 33012
Contact: Luis Carlos Quintero, Site 0011    305-670-8830      
Genesis Clinical Research, Inc. Terminated
Tampa, Florida, United States, 33614
United States, Georgia
Emory University School Of Medicine Recruiting
Atlanta, Georgia, United States, 30303
Contact: Guillermo Umpierrez, Site 0012    404-778-1665      
Endocrine Research Solutions, Inc. Recruiting
Roswell, Georgia, United States, 30076
Contact: John Chip H Reed, Iii, Site 0002    678-904-5259      
United States, Illinois
John H. Stroger, Jr. Hospital Of Cook County Recruiting
Chicago, Illinois, United States, 60612
Contact: Leon Fogelfeld, Site 0060    312-864-0539      
Research By Design, Llc Recruiting
Evergreen Park, Illinois, United States, 60805
Contact: Paul Wesley Crawford, Site 0050    708-952-4644      
United States, Missouri
St Louis Center Clinl Res Recruiting
Saint Louis, Missouri, United States, 63128
Contact: Asim Ali, Site 0014    314-543-5225      
United States, Nebraska
Va Nebraska-Western Iowa Health Care System (Nwihcs) Recruiting
Omaha, Nebraska, United States, 68105
Contact: Robert J Anderson, Site 0028    402-995-4747      
United States, New Hampshire
Southern Nh Diab And Endo Recruiting
Nashua, New Hampshire, United States, 03063
Contact: Robert Jeffrey Silver, Site 0072    603-577-7574      
United States, New Jersey
Premier Research, Inc. Recruiting
Trenton, New Jersey, United States, 08611
Contact: Jane Rohlf, Site 0016    609-392-6666      
United States, New York
The Endocrine Group Llp Recruiting
Albany, New York, United States, 12206
Contact: Robert Busch, Site 0006    518-489-4704      
Nephrology Associates Recruiting
Flushing, New York, United States, 11355
Contact: Chaim Charytan, Site 0059    718-670-1151      
United States, North Carolina
Medispect Medical Research, Llc Recruiting
Boone, North Carolina, United States, 28607
Contact: Marshall Murrey, Site 0013    352-266-2625      
Metrolina Internal Medicine Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Karlton Pettis, Site 0007    704-377-6906      
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: John Paul Middleton, Site 0055    214-648-3442      
United States, Ohio
Local Institution Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Site 0073         
Paramount Medical Research & Consulting, Llc Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact: Isam A Diab, Site 0001    440-826-0742      
Physician Research, Inc. Terminated
Zanesville, Ohio, United States, 43701
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Intekhab Ahmed, Site 0004    215-955-3823      
United States, South Carolina
Piedmont Health Grp, Llc-Twr Pt Res Ctr Recruiting
Hodges, South Carolina, United States, 29653
Contact: Oliver Willard, Site 0033    864-943-4849      
Strand Physician Specialists, Pa Withdrawn
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Anna Burgner, Site 0069    615-936-1179      
United States, Texas
Doctors Hospital At Renaissance Recruiting
Edinburg, Texas, United States, 78539
Contact: Marcel Twahirwa, Site 0067    956-362-5675      
San Antonio Military Medical Center Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Ahmad M Slim, Site 0051    210-916-5451      
Northeast Clinical Research Of San Antonio, Llc Recruiting
Schertz, Texas, United States, 78154
Contact: Laura Akright, Site 0070    210-581-0045      
United States, Virginia
Burke Internal Medicine And Research Recruiting
Burke, Virginia, United States, 22015
Contact: Nashwa Gabra, Site 0008    703-455-9711      
Virginia Endocrinology Research Recruiting
Chesapeake, Virginia, United States, 23321
Contact: James Larocque, Site 0066         
Manassas Clinical Research Center Recruiting
Manassas, Virginia, United States, 20110
Contact: Nabil Andrawis, Site 0005    703-330-1112      
Mcguire Va Medical Center Recruiting
Richmond, Virginia, United States, 23249
Contact: Franklin Zieve, Site 0025    804-272-7047      
Canada, Manitoba
Health Sciences Centre Diabetes Research Centre Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: Vincent Woo, Site 0046    204-789-3837      
Canada, Newfoundland and Labrador
Eastern Health Sciences Center Recruiting
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Carol Joyce, Site 0054    709-777-7621      
Canada, Ontario
Aggarwal And Associates Recruiting
Brampton, Ontario, Canada, L6T 0G1
Contact: Naresh Aggarwal, Site 0026    905-792-6500      
Clinical Research Solutions, Inc Recruiting
Kitchener, Ontario, Canada, N2H 5Z8
Contact: Shivinder Jolly, Site 0075    519-743-2573      
Lmc Diabetes & Endocrinology (Thornhill) Completed
Thornhill, Ontario, Canada, L4J 8L7
Lmc Diabetes & Endocrinology (Bayview) Terminated
Toronto, Ontario, Canada, M4G 3E8
Canada, Quebec
Centre De Recherche Clinique De Laval Terminated
Laval, Quebec, Canada, H7T 2P5
Recherche Gcp Research Terminated
Montreal, Quebec, Canada, H2R 1V6
Local Institution Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Site 0065         
Denmark
Local Institution Recruiting
Frederiksberg, Denmark, 2000
Contact: Site 0053         
Local Institution Recruiting
Gentofte, Denmark, 2820
Contact: Site 0052         
Local Institution Recruiting
Hillerod, Denmark, 3400
Contact: Site 0068         
Local Institution Recruiting
Holstebro, Denmark, 7500
Contact: Site 0071         
France
Local Institution Recruiting
Amiens Cedex 1, France, 80054
Contact: Site 0061         
Local Institution Recruiting
Grenoble Cedex 9, France, F38043
Contact: Site 0049         
Local Institution Recruiting
Nantes Cedex 1, France, 44093
Contact: Site 0058         
Local Institution Recruiting
Paris, France, 75877
Contact: Site 0056         
Local Institution Recruiting
Poitiers Cedex, France, 86021
Contact: Site 0047         
Local Institution Recruiting
Tours Cedex 09, France, 37044
Contact: Site 0057         
Puerto Rico
Pavia Research Center, Llc Withdrawn
San Juan, Puerto Rico, 00909
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: September 22, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on October 01, 2014