A Glomerular Filtration Rate (GFR) Measuring Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus

Phase 2TerminatedNCT01572610

Kyowa Kirin Co., Ltd.11 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Kidney Disease Type 2 Diabetes

Interventions

RTA 402DRUG

once a day, oral administration

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 * Patients for whom Inulead® injection is contraindicated etc.

Locations (1)

Unnamed facility

Koga, Ibaraki, Japan

Outcomes

Primary Outcomes

Efficacy: glomerular filtration rate measured by inulin clearance

Individual subjects' change from baseline in GFR measured by inulin clearance will be evaluated.

Time frame: Up to 16 weeks

Adverse Event collection and assessment

Adverse Event collection

Time frame: Up to 16 weeks

Data from ClinicalTrials.gov

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