A Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus
- Registration Number
- NCT01574365
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
A Phase 2 study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 53
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 etc.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RTA402 Medium-high RTA 402 - RTA402 Low RTA 402 - RTA402 Medium-low RTA 402 - RTA402 RTA 402 -
- Primary Outcome Measures
Name Time Method Adverse event collection and assessment Up to 16 weeks Adverse Event collection and assessment will be done for all treated subjects.
Efficacy:Changes in eGFR Up to 16 weeks Changes in eGFR from baseline to the study week 12 or to the time of treatment discontinuation.
- Secondary Outcome Measures
Name Time Method Profile of Pharmacokinetics Baseline, week 4, 8 and 12. Relationship between the study drug dose and the trough concentration of study drug