A Glomerular Filtration Rate (GFR) Measuring Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus
- Registration Number
- NCT01572610
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
A Phase 2 glomerular filtration rate (GFR) measuring study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RTA 402 RTA 402 -
- Primary Outcome Measures
Name Time Method Efficacy: glomerular filtration rate measured by inulin clearance Up to 16 weeks Individual subjects' change from baseline in GFR measured by inulin clearance will be evaluated.
Adverse Event collection and assessment Up to 16 weeks Adverse Event collection
- Secondary Outcome Measures
Name Time Method