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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Diabetes
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - 85
Updated:4/21/2016
Start Date:March 2013
End Date:June 2015

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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


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
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Boone, North Carolina 28607
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
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Durham, North Carolina 27710
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Albany, New York 12206
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Birmingham, Alabama 35294
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Burke, Virginia 22015
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Charlotte, North Carolina 28204
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Chesapeake, Virginia 23321
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1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Cooper City, Florida 33024
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Edinburg, Texas 78539
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Evergreen Park, Illinois 60805
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Flushing, New York 11355
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Fort Sam Houston, Texas 78234
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Hodges, South Carolina 29646
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Los Angeles, California 90022
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Los Angeles, California 90095
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Manassas, Virginia 20110
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Middleburg Heights, Ohio 44130
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Nashua, New Hampshire 03063
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North Hollywood, California 91606
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Northridge, California 91325
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Phoenix, Arizona 85012
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Richmond, Virginia 23249
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Roswell, Georgia 30076
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Saint Louis, Missouri 63128
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Tampa, Florida 33614
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Trenton, New Jersey 08611
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Walnut creek, California 94598
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Washington, District of Columbia 20037
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Zanesville, Ohio 43701
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