A Phase 2, Double-Blind, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy, Safety, and Tolerability of GS-4997 in Subjects With Diabetic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 334
- 试验地点
- 101
- 主要终点
- Change in eGFR From Baseline at Week 48
研究概览
简要总结
The primary objective of this study is to determine the effect of selonsertib (formerly GS-4997) on estimated glomerular filtration rate (eGFR) decline in participants with diabetic kidney disease (DKD). Participants will be randomized with a 1:1:1:1 allocation to receive 1 of 3 doses of selonsertib (2 mg, 6 mg, or 18 mg) or matching placebo.
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
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or females with prior diagnosis of Diabetic Kidney Disease
- •Type 2 diabetes mellitus diagnosis for at least 6 months
- •eGFR (MDRD) at screening ≥ 15 mL/min/1.73m^2 to < 60 mL/min/1.73m^2
- •Urine albumin to creatinine ratio (UACR) as follows:
- •Stage/Stratum 3a: eGFR range 45 to < 60 mL/min; UACR ≥ 600 mg/g
- •Stage/Stratum 3b: eGFR range 30 to < 45 mL/min; UACR ≥ 300 mg/g
- •Stage/Stratum 4: eGFR range 15 to < 30 mL/min; UACR ≥ 150 mg/g
- •Receiving angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor blockers (ARB) at a minimum dose deemed appropriate for the individual by the investigator and be at a stable dose for the last three months
- •Individuals not on ACEi/ARB may be screened if there is documented intolerance to ACE inhibitor and/or ARB
排除标准
- •Type 1 diabetes mellitus
- •HbA1c > 9.5%
- •Non-diabetic kidney disease
- •UACR > 5000 mg/g on any measurement during screening
- •End stage renal disease (ESRD; receiving peritoneal dialysis, hemodialysis, or status post renal transplantation) or anticipated to occur within the treatment period
- •Unstable cardiovascular disease
- •Pregnant or lactating females
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Selonsertib 2 mg
Participants will receive selonsertib 2 mg for 48 weeks.
干预措施: Selonsertib (Drug)
Selonsertib 6 mg
Participants will receive selonsertib 6 mg for 48 weeks.
干预措施: Selonsertib (Drug)
Selonsertib 18 mg
Participants will receive selonsertib 18 mg for 48 weeks.
干预措施: Selonsertib (Drug)
Placebo to match selonsertib
Participants will receive placebo to match selonsertib for 48 weeks.
干预措施: Placebo to match selonsertib (Drug)
结局指标
主要结局
Change in eGFR From Baseline at Week 48
时间窗: Baseline; Week 48
The values of eGFR were calculated using the MDRD equation: eGFR = 175 x Serum Creatinine\^-1.154 × age\^-0.203 × 1.212 (if participant is black) × 0.742 (if female).
次要结局
- Percentage of Participants Achieving at Least a 30% Reduction From Baseline in Albuminuria (As Measured by Urine Albumin to Creatinine Ratio) at Week 48(Baseline; Week 48)