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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Diabetic Kidney Disease

In brief

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

Key facts

Study ID

NCT01752985

Run by

Bristol-Myers Squibb

People needed

319

Starts

2013-03-18

Expected to finish

2015-06-30

Last updated by the study team

2019-07-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Univ Of Al At Birmingham — Birmingham, Alabama, United States
• Akdhc Medical Research Services Llc — Phoenix, Arizona, United States
• Academic Medical Research Institute — Los Angeles, California, United States
• Ucla — Los Angeles, California, United States
• Providence Clinical Research — North Hollywood, California, United States
• Diabetes Medical Center Of California — Northridge, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• George Washington University Medical Faculty Associates — Washington D.C., District of Columbia, United States
• All Medical Research, Llc — Cooper City, Florida, United States
• International Research Associates, Llc — Hialeah, Florida, United States
• Genesis Clinical Research, Inc. — Tampa, Florida, United States
• Emory University School Of Medicine — Atlanta, Georgia, United States
• Endocrine Research Solutions, Inc. — Roswell, Georgia, United States
• John H. Stroger, Jr. Hospital Of Cook County — Chicago, Illinois, United States
• Research By Design, Llc — Evergreen Park, Illinois, United States
• St Louis Center Clinl Res — St Louis, Missouri, United States
• St. Louis Center For Clinical Research — St Louis, Missouri, United States
• Va Nebraska-Western Iowa Health Care System (Nwihcs) — Omaha, Nebraska, United States
• Southern Nh Diab And Endo — Nashua, New Hampshire, United States
• Premier Research, Inc. — Trenton, New Jersey, United States
• Albany Medical College — Albany, New York, United States
• The Endocrine Group Llp — Albany, New York, United States
• Nephrology Associates — Flushing, New York, United States
• Medispect Medical Research, Llc — Boone, North Carolina, United States
• Uab Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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