A Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus

Phase 2TerminatedNCT01574365

Kyowa Kirin Co., Ltd.53 enrolled

Overview

A Phase 2 study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Kidney Disease Type 2 Diabetes

Interventions

RTA 402DRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Toride, Ibaraki, Japan

Outcomes

Primary Outcomes

Efficacy:Changes in eGFR

Changes in eGFR from baseline to the study week 12 or to the time of treatment discontinuation.

Time frame: Up to 16 weeks

Adverse event collection and assessment

Adverse Event collection and assessment will be done for all treated subjects.

Time frame: Up to 16 weeks

Secondary Outcomes

Profile of Pharmacokinetics

Relationship between the study drug dose and the trough concentration of study drug

Time frame: Baseline, week 4, 8 and 12.

Data from ClinicalTrials.gov

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