Clinical trial NCT01752985: Study to Evaluate the Effects of BMS-813160 on Protein Loss in the Urine of Subjects With Type 2 Diabetes and Diabetic Kidney Disease
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetic Kidney Disease
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-12-19
Enrollment: 319
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment With BMS-813160
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 16 (Follow-up)
Secondary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs), Who Died and With Other (Not Including Serious) Adverse Events
timeFrame: From the date of subject's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
measure: Number of Participants With Out-of-Range Electrocardiogram (ECG) Interval
timeFrame: Baseline up to Week 16
measure: Trough Observed Plasma Concentration (Ctrough) of BMS-813160
timeFrame: Pre-dose at Week 2, 4, 8, 12 and 0.5, 1, 2, 4, and 6 hours post-dose at Week 12
measure: Area Under The Plasma Concentration-Time Curve From Time Zero to 6 Hours Post-Dose [AUC(0-6 h)]
timeFrame: Pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose at Week 12
measure: Renal Clearance (CLr) of BMS-813160
timeFrame: Pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose at Week 12
measure: Dose-Response Relationship Using Change in Baseline Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment
timeFrame: Baseline, Weeks 2, 4, 8 and 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Uab Hospital
state: Alabama
city: Birmingham
country: United States
facility: Univ Of Al At Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Akdhc Medical Research Services Llc
state: Arizona
city: Los Angeles
country: United States
facility: Academic Medical Research Institute
state: California
city: Los Angeles
country: United States
facility: Ucla
state: California
city: North Hollywood
country: United States
facility: Providence Clinical Research
state: California
city: Northridge
country: United States
facility: Diabetes Medical Center Of California
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
city: Cooper City
country: United States
facility: All Medical Research, Llc
state: Florida
city: Hialeah
country: United States
facility: International Research Associates, Llc
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research, Inc.
state: Florida
city: Atlanta
country: United States
facility: Emory University School Of Medicine
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Chicago
country: United States
facility: John H. Stroger, Jr. Hospital Of Cook County
state: Illinois
city: Evergreen Park
country: United States
facility: Research By Design, Llc
state: Illinois
city: Saint Louis
country: United States
facility: St Louis Center Clinl Res
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Center For Clinical Research
state: Missouri
city: Omaha
country: United States
facility: Va Nebraska-Western Iowa Health Care System (Nwihcs)
state: Nebraska
city: Nashua
country: United States
facility: Southern Nh Diab And Endo
state: New Hampshire
city: Trenton
country: United States
facility: Premier Research, Inc.
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Albany
country: United States
facility: The Endocrine Group Llp
state: New York
city: Flushing
country: United States
facility: Nephrology Associates
state: New York
city: Boone
country: United States
facility: Medispect Medical Research, Llc
state: North Carolina
city: Charlotte
country: United States
facility: Metrolina Internal Medicine
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting, Llc
state: Ohio
city: Zanesville
country: United States
facility: Physician Research, Inc.
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Hodges
country: United States
facility: Piedmont Health Grp, Llc-Twr Pt Res Ctr
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Edinburg
country: United States
facility: Doctors Hospital At Renaissance
state: Texas
city: Fort Sam Houston
country: United States
facility: San Antonio Military Medical Center
state: Texas
city: Fort Sam Houston
country: United States
facility: San Antonio Military Medical Center
state: Texas
city: Schertz
country: United States
facility: Northeast Clinical Research Of San Antonio, Llc
state: Texas
city: Burke
country: United States
facility: Burke Internal Medicine And Research
state: Virginia
city: Chesapeake
country: United States
facility: Virginia Endocrinology Research
state: Virginia
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Richmond
country: United States
facility: Mcguire Va Medical Center
state: Virginia
city: Winnipeg
country: Canada
facility: Health Sciences Centre Diabetes Research Centre
state: Manitoba
city: St. John's
country: Canada
facility: Eastern Health Sciences Center
state: Newfoundland and Labrador
city: Brampton
country: Canada
facility: Aggarwal And Associates
state: Ontario
city: Kitchener
country: Canada
facility: Clinical Research Solutions, Inc
state: Ontario
city: Thornhill
country: Canada
facility: Lmc Diabetes & Endocrinology (Thornhill)
state: Ontario
city: Toronto
country: Canada
facility: Lmc Diabetes & Endocrinology (Bayview)
state: Ontario
city: Laval
country: Canada
facility: Centre De Recherche Clinique De Laval
state: Quebec
city: Montreal
country: Canada
facility: Recherche Gcp Research
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Frederiksberg
country: Denmark
facility: Local Institution
city: Gentofte
country: Denmark
facility: Local Institution
city: Hillerod
country: Denmark
facility: Local Institution
city: Holstebro
country: Denmark
facility: Local Institution
city: Amiens Cedex 1
country: France
facility: Local Institution
city: Grenoble Cedex 9
country: France
facility: Local Institution
city: Nantes Cedex 1
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Poitiers Cedex
country: France
facility: Local Institution
city: Tours Cedex 09
country: France
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: