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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
319
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.
Time frame: Baseline, Weeks 2, 4, 8, 12, and 16 (Follow-up)
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.
Time frame: 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).
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Uab Hospital
Birmingham, Alabama, United States
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
...and 52 more locations
Time frame: Baseline up to Week 16
Trough Observed Plasma Concentration (Ctrough) of BMS-813160
Ctrough is the minimum estimated plasma concentration at steady state.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline, Weeks 2, 4, 8 and 12