RTA 402 Phase 2 Clinical Trial (A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients With Chronic Kidney Disease and Type 2 Diabetes)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 216
- 主要终点
- Safety: Number and types of adverse events
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of RTA 402 in chronic kidney disease (CKD) patients with type 2 diabetes in a double-blind, placebo-controlled study when this compound is administered once daily for 16 weeks in an intrapatient dose escalation design.
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
- •CKD patients with type 2 diabetes mellitus
- •Patients whose estimated GFR levels are eligible for this study
- •Patients being treated with stable dose of angiotensin converting enzyme (ACE) inhibitors and/or angiotensin II receptor blocker (ARB) etc.
排除标准
- •Patients with type 1 diabetes mellitus
- •Patients with known non-diabetic renal disease
- •Patients with a history of renal transplantation
- •Patients with mean systolic blood pressure > 160 mmHg or diastolic blood pressure > 90 mmHg
- •Patients with Hemoglobin A1c > 10%
- •Patients with cardiovascular disease specified in the study protocol etc.
研究组 & 干预措施
bardoxolone methyl
bardoxolone methyl capsules, dosage To Be Determined, once daily for 16 weeks
干预措施: RTA 402 (Drug)
Placebo
Placebo capsules, once daily for 16 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Safety: Number and types of adverse events
时间窗: Up to 16 weeks
Count of adverse events, by type, in the bardoxolone methyl arm compared to the placebo arm
Change in glomerular filtration rate (GFR) measured by inulin clearance after 16 weeks of study drug administration, compared to baseline GFR
时间窗: Up to 16 weeks
Change in GFR from baseline to 16 weeks
次要结局
- Profiles of pharmacokinetics of plasma RTA 402 concentration: Trough (Pre-dose) and peak (2-4 hours post dose) concentrations of study drug at steady state(Baseline, week 2, 6, 10, and 4 weeks after completion of study treatment)
- Change in estimated GFR (eGFR) after 16 weeks of study drug administration, compared to baseline eGFR(Up to 16 weeks)