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 15, 2014
Last verified: August 2014

December 17, 2012
September 15, 2014
March 2013
January 2016   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01752985 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
  • 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 ]
Not Provided
Not Provided
 
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 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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetic Kidney Disease
  • Drug: BMS-813160
  • Drug: Placebo matching with BMS-813160
  • 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
    Interventions:
    • 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
    Intervention: 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
    Intervention: Drug: Placebo matching with BMS-813160
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
January 2016
January 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
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 #.
United States,   Canada,   Denmark,   France,   Puerto Rico
 
NCT01752985
CV202-010, 2012-005093-54
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP