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

Kyowa Kirin

Status and phase: Terminated; Phase 2

Conditions: Chronic Kidney Disease; Type 2 Diabetes

Treatments: Drug: RTA 402

Study type: Interventional

Funder types: Industry

Identifiers

NCT01574365

RTA 402-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 4 patient groups

RTA402

Experimental group

Treatment:

Drug: RTA 402

RTA402 Low

Experimental group

Treatment:

Drug: RTA 402

RTA402 Medium-low

Experimental group

Treatment:

Drug: RTA 402

RTA402 Medium-high

Experimental group

Treatment:

Drug: RTA 402