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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 319
- 试验地点
- 50
- 主要终点
- Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment With BMS-813160
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm A: BMS-813160 150 mg & Placebo matching with BMS-813160
BMS-813160 150 mg capsules by mouth in AM and Placebo matching with BMS-813160 in PM for 12 weeks
干预措施: Placebo matching with BMS-813160 (Drug)
Arm A: BMS-813160 150 mg & Placebo matching with BMS-813160
BMS-813160 150 mg capsules by mouth in AM and Placebo matching with BMS-813160 in PM for 12 weeks
干预措施: BMS-813160 (Drug)
Arm B: BMS-813160 300 mg
BMS-813160 300 mg capsules by mouth twice daily for 12 weeks
干预措施: BMS-813160 (Drug)
Arm C: Placebo matching with BMS-813160
Placebo matching with BMS-813160 0 mg capsules by mouth twice daily for 12 weeks
干预措施: Placebo matching with BMS-813160 (Drug)
结局指标
主要结局
Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment With BMS-813160
时间窗: Baseline, Weeks 2, 4, 8, 12, and 16 (Follow-up)
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.
次要结局
- Number of Participants With Serious Adverse Events (SAEs), Who Died and With Other (Not Including Serious) Adverse Events(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(Baseline up to Week 16)
- Area Under The Plasma Concentration-Time Curve From Time Zero to 6 Hours Post-Dose [AUC(0-6 h)](Pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose at Week 12)
- Trough Observed Plasma Concentration (Ctrough) of BMS-813160(Pre-dose at Week 2, 4, 8, 12 and 0.5, 1, 2, 4, and 6 hours post-dose at Week 12)
- Renal Clearance (CLr) of BMS-813160(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(Baseline, Weeks 2, 4, 8 and 12)