| Outcome Measures: |
Primary: Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment With BMS-813160, The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples. UACR was calculated as the geometric mean of two first-morning void urine UACR measurements with samples collected on two separate occasions within a 4-day period., Baseline, Weeks 2, 4, 8, 12, and 16 (Follow-up) | Secondary: Number of Participants With Serious Adverse Events (SAEs), Who Died and With Other (Not Including Serious) Adverse Events, An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event., From the date of subject's written consent until 30 days post discontinuation of dosing, assessed up to 26 months|Number of Participants With Out-of-Range Electrocardiogram (ECG) Interval, 12-lead ECGs were performed before and 1 hour after dosing at Weeks 0, 2 and 4. ECGs were recorded after the participant has been supine for at least 5 minutes. The PR interval was defined as the beginning of the P wave to the beginning of the QRS complex, and represents the time taken by electrical impulse to travel from the sinus node through the atrioventricular (AV) node. The QRS complex represented the rapid depolarization of the right and left ventricles. The QT interval was defined as the time from the start of the Q wave to the end of the T wave, and represents the time taken for ventricular depolarization and repolarization. Participants were evaluated for abnormal ECG intervals. Criteria's for abnormality were PR \>200, QRS \>120, QT \>500, QTcF \>450, Change From Baseline \>30 milliseconds (msec)., Baseline up to Week 16|Trough Observed Plasma Concentration (Ctrough) of BMS-813160, Ctrough is the minimum estimated plasma concentration at steady state., Pre-dose at Week 2, 4, 8, 12 and 0.5, 1, 2, 4, and 6 hours post-dose at Week 12|Area Under The Plasma Concentration-Time Curve From Time Zero to 6 Hours Post-Dose [AUC(0-6 h)], AUC(0-6 h) is the area under the plasma concentration-time curve from pre-dose (0 h) to 6 h post-dose., Pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose at Week 12|Renal Clearance (CLr) of BMS-813160, CLr was calculated by dividing the total amount excreted in the urine from 0 to 6 hours by the area under the plasma concentration-time curve from time zero extrapolated to infinite time. The renal function was classified based on estimated glomerular filtration rate as normal (\>=90 mL/min/1.73 m\^2), mildly impaired (60-89 mL/min/1.73 m\^2), moderately impaired stage 3A (45-59 mL/min/1.73 m\^2), and moderately impaired stage 3B (30-44 L/min/1.73 m\^2)., Pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose at Week 12|Dose-Response Relationship Using Change in Baseline Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment, The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples. UACR was calculated as the geometric mean of two first-morning void urine UACR measurements with samples collected on two separate occasions within a 4-day period. The effect of BMS-813160 on urinary albumin excretion as measured by UACR values in participants with diabetic kidney disease after 12 weeks of treatment was assessed. The model included treatment group as a main effect, and the log of baseline UACR values, as well as baseline values of eGFR, blood pressure, blood glucose and lipid levels, as covariates., Baseline, Weeks 2, 4, 8 and 12
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| Locations: |
Uab Hospital, Birmingham, Alabama, 35294, United States|Univ Of Al At Birmingham, Birmingham, Alabama, 35294, United States|Akdhc Medical Research Services Llc, Phoenix, Arizona, 85012, United States|Academic Medical Research Institute, Los Angeles, California, 90022, United States|Ucla, Los Angeles, California, 90025, United States|Providence Clinical Research, North Hollywood, California, 91606, United States|Diabetes Medical Center Of California, Northridge, California, 91325, United States|Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States|George Washington University Medical Faculty Associates, Washington, District of Columbia, 20037, United States|All Medical Research, Llc, Cooper City, Florida, 33024, United States|International Research Associates, Llc, Hialeah, Florida, 33012, United States|Genesis Clinical Research, Inc., Tampa, Florida, 33614, United States|Emory University School Of Medicine, Atlanta, Georgia, 30303, United States|Endocrine Research Solutions, Inc., Roswell, Georgia, 30076, United States|John H. Stroger, Jr. Hospital Of Cook County, Chicago, Illinois, 60612, United States|Research By Design, Llc, Evergreen Park, Illinois, 60805, United States|St Louis Center Clinl Res, Saint Louis, Missouri, 63128, United States|St. Louis Center For Clinical Research, Saint Louis, Missouri, 63128, United States|Va Nebraska-Western Iowa Health Care System (Nwihcs), Omaha, Nebraska, 68105, United States|Southern Nh Diab And Endo, Nashua, New Hampshire, 03063, United States|Premier Research, Inc., Trenton, New Jersey, 08611, United States|Albany Medical College, Albany, New York, 12206, United States|The Endocrine Group Llp, Albany, New York, 12206, United States|Nephrology Associates, Flushing, New York, 11355, United States|Medispect Medical Research, Llc, Boone, North Carolina, 28607, United States|Metrolina Internal Medicine, Charlotte, North Carolina, 28204, United States|Duke University, Durham, North Carolina, 27705, United States|Ohio State University Medical Center, Columbus, Ohio, 43210, United States|The Ohio State University Wexner Medical Center, Columbus, Ohio, 43210, United States|Paramount Medical Research & Consulting, Llc, Middleburg Heights, Ohio, 44130, United States|Physician Research, Inc., Zanesville, Ohio, 43701, United States|Thomas Jefferson University, Philadelphia, Pennsylvania, 19107, United States|Piedmont Health Grp, Llc-Twr Pt Res Ctr, Hodges, South Carolina, 29653, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232-1371, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States|Doctors Hospital At Renaissance, Edinburg, Texas, 78539, United States|San Antonio Military Medical Center, Fort Sam Houston, Texas, 78234-6200, United States|San Antonio Military Medical Center, Fort Sam Houston, Texas, 78234, United States|Northeast Clinical Research Of San Antonio, Llc, Schertz, Texas, 78154, United States|Burke Internal Medicine And Research, Burke, Virginia, 22015, United States|Virginia Endocrinology Research, Chesapeake, Virginia, 23321, United States|Manassas Clinical Research Center, Manassas, Virginia, 20110, United States|Mcguire Va Medical Center, Richmond, Virginia, 23249, United States|Health Sciences Centre Diabetes Research Centre, Winnipeg, Manitoba, R3A 1R9, Canada|Eastern Health Sciences Center, St. John's, Newfoundland and Labrador, A1B 3V6, Canada|Aggarwal And Associates, Brampton, Ontario, L6T 0G1, Canada|Clinical Research Solutions, Inc, Kitchener, Ontario, N2H 5Z8, Canada|Lmc Diabetes & Endocrinology (Thornhill), Thornhill, Ontario, L4J 8L7, Canada|Lmc Diabetes & Endocrinology (Bayview), Toronto, Ontario, M4G 3E8, Canada|Centre De Recherche Clinique De Laval, Laval, Quebec, H7T 2P5, Canada|Recherche Gcp Research, Montreal, Quebec, H2R 1V6, Canada|Local Institution, Montreal, Quebec, H3T 1E2, Canada|Local Institution, Frederiksberg, 2000, Denmark|Local Institution, Gentofte, 2820, Denmark|Local Institution, Hillerod, 3400, Denmark|Local Institution, Holstebro, 7500, Denmark|Local Institution, Amiens Cedex 1, 80054, France|Local Institution, Grenoble Cedex 9, F38043, France|Local Institution, Nantes Cedex 1, 44093, France|Local Institution, Paris, 75877, France|Local Institution, Poitiers Cedex, 86021, France|Local Institution, Tours Cedex 09, 37044, France
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