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

• Status: Terminated
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.

Criteria

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.