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Clinical Trials/NCT01574365
NCT01574365TerminatedPhase 2

A Phase 2 Study of RTA 402 in CKD Patients With Type 2 Diabetes Mellitus

Kyowa Kirin Co., Ltd.0 sites53 target enrollmentStarted: February 2012Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
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

Sponsor Class
Industry
Responsible Party
Sponsor

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