NCT01572610终止2 期
A Phase 2 GFR Measuring 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
- 11
- 主要终点
- Efficacy: glomerular filtration rate measured by inulin clearance
研究概览
简要总结
A Phase 2 glomerular filtration rate (GFR) measuring study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.
详细描述
An exploratory study to investigate the effects of RTA 402 on glomerular filtration rate in CKD patients with type 2 diabetes mellitus.
To evaluate the safety of RTA 402.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients for whom Inulead® injection is contraindicated etc.
研究组 & 干预措施
RTA 402
Experimental
干预措施: RTA 402 (Drug)
结局指标
主要结局
Efficacy: glomerular filtration rate measured by inulin clearance
时间窗: Up to 16 weeks
Individual subjects' change from baseline in GFR measured by inulin clearance will be evaluated.
Adverse Event collection and assessment
时间窗: Up to 16 weeks
Adverse Event collection
次要结局
未报告次要终点
研究者
相似试验
未知
2 期
A Phase 2 GFR Measuring Study of RTA 402 in CKD Patients With Type 2 Diabetes MellitusJPRN-jRCT2080221750Kyowa Hakko Kirin Co., Ltd.20
终止
2 期
A Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes MellitusType 2 DiabetesChronic Kidney DiseaseNCT01574365Kyowa Kirin Co., Ltd.53
已完成
2 期
The Phase II Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes; TSUBAKI StudyType 2 DiabetesChronic Kidney DiseaseNCT02316821Kyowa Kirin Co., Ltd.216
未知
2 期
A Phase 2 Study of RTA 402 in CKD Patients With Type 2 Diabetes MellitusJPRN-jRCT2080221749Kyowa Hakko Kirin Co., Ltd.40
尚未招募
不适用
Comparison of Different Gfr Measurements in Chronic Kidney DiseasesChronic Kidney DiseasesNCT05696028Assiut University166