NCT01574365终止2 期
A Phase 2 Study of RTA 402 in CKD Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 53
- 主要终点
- Adverse event collection and assessment
研究概览
简要总结
A Phase 2 study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.
详细描述
To evaluate the efficacy and safety of RTA 402 in patients with type 2 diabetes mellitus.
To evaluate the safety and tolerability of RTA 402.
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
- None
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 eGFR levels are eligible for this study
- •Patients being treated with stable dose of ACE inhibitors and/or ARB etc.
排除标准
- •Patients with Type 1 diabetes
- •Patients with known non-diabetic renal disease
- •Patients with a history of renal transplantation
- •Patients with mean SBP > 160 mmHg or mean DBP > 90 mmHg
- •Patients with HbA1C > 10%
- •Patients with cardiovascular disease specified in the study protocol etc.
研究组 & 干预措施
RTA402
Experimental
干预措施: RTA 402 (Drug)
RTA402 Low
Experimental
干预措施: RTA 402 (Drug)
RTA402 Medium-low
Experimental
干预措施: RTA 402 (Drug)
RTA402 Medium-high
Experimental
干预措施: RTA 402 (Drug)
结局指标
主要结局
Adverse event collection and assessment
时间窗: Up to 16 weeks
Adverse Event collection and assessment will be done for all treated subjects.
Efficacy:Changes in eGFR
时间窗: Up to 16 weeks
Changes in eGFR from baseline to the study week 12 or to the time of treatment discontinuation.
次要结局
- Profile of Pharmacokinetics(Baseline, week 4, 8 and 12.)
研究者
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