RTA 402 Phase 3 Clinical Trial (A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients With Diabetic Kidney Disease)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1,323
- 试验地点
- 1
- 主要终点
- Time to onset of a ≥ 30% decrease in eGFR from baseline or ESRD
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy of multiple oral doses of RTA 402 (5, 10, or 15 mg) administered once daily in patients with diabetic kidney disease (DKD) using the time to onset of a ≥ 30% decrease in estimated glomerular filtration rate calculated from serum creatinine (eGFR) from baseline or end-stage renal disease (ESRD) as an indicator in a randomized, double-blind, placebo-controlled study; the safety of RTA 402 will also be evaluated.
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with DKD
- •Mean eGFR ≥ 15 and < 60 mL/min/1.73 m²
- •Albumin/creatinine ratio (ACR) ≤ 3500 mg/g Cr
- •Treatment with an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) with no change in dosage or medication etc.
排除标准
- •Diabetes mellitus that is neither type 1 nor type 2
- •Decreased renal function mainly attributed to a non-diabetic cause
- •History of renal transplantation or upcoming preemptive renal transplantation
- •Confirmed mean systolic blood pressure > 160 mmHg or a confirmed mean diastolic blood pressure > 90 mmHg during the 8-week period before screening
- •Hemoglobin A1c level > 10.0% during screening
- •Serum albumin level ≤ 3.0 g/dL during screening
- •Cardiovascular disease specified in the study protocol
- •History of cardiac failure
- •BNP level > 200 pg/mL during screening etc.
研究组 & 干预措施
RTA 402(Bardoxolone methyl)
Patients will receive multiple oral doses of bardoxolone methyl once daily. The starting dose of bardoxolone methyl will be 5 mg. The maximum dose will be 15 mg, and the dose will be increased by 5 mg.
干预措施: Bardoxolone methyl (Drug)
Placebo
Patients randomized to placebo will remain on placebo throughout the study, undergoing sham titration.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to onset of a ≥ 30% decrease in eGFR from baseline or ESRD
时间窗: Through double-blind part completion, approximately 3 to 4 years
次要结局
- Time to onset of ESRD(Through double-blind part completion, approximately 3 to 4 years)
- Time to onset of a ≥ 40% decrease in eGFR from baseline or ESRD(Through double-blind part completion, approximately 3 to 4 years)
- Time to onset of a ≥ 53% decrease in eGFR from baseline or ESRD(Through double-blind part completion, approximately 3 to 4 years)
- Change in eGFR from baseline at each evaluation time point(Through double-blind part completion, approximately 3 to 4 years)