NCT01574365TerminatedPhase 2
A Phase 2 Study of RTA 402 in CKD Patients With Type 2 Diabetes Mellitus
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Kyowa Kirin Co., Ltd.
- Enrollment
- 53
- Primary Endpoint
- Adverse event collection and assessment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
RTA402
Experimental
Intervention: RTA 402 (Drug)
RTA402 Low
Experimental
Intervention: RTA 402 (Drug)
RTA402 Medium-low
Experimental
Intervention: RTA 402 (Drug)
RTA402 Medium-high
Experimental
Intervention: RTA 402 (Drug)
Outcomes
Primary Outcomes
Adverse event collection and assessment
Time Frame: Up to 16 weeks
Adverse Event collection and assessment will be done for all treated subjects.
Efficacy:Changes in eGFR
Time Frame: Up to 16 weeks
Changes in eGFR from baseline to the study week 12 or to the time of treatment discontinuation.
Secondary Outcomes
- Profile of Pharmacokinetics(Baseline, week 4, 8 and 12.)
Investigators
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