A Phase 3 Study of Bardoxolone Methyl in Patients With Diabetic Kidney Disease; AYAME Study

• Status: Active, not recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate the efficacy of multiple oral doses of RTA 402 (5, 10, or 15 mg) administered once daily in patients with diabetic kidney disease (DKD) using the time to onset of a ≥ 30% decrease in estimated glomerular filtration rate calculated from serum creatinine (eGFR) from baseline or end-stage renal disease (ESRD) as an indicator in a randomized, double-blind, placebo-controlled study; the safety of RTA 402 will also be evaluated.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Patients with DKD

• Mean eGFR ≥ 15 and < 60 mL/min/1.73 m²

• Albumin/creatinine ratio (ACR) ≤ 3500 mg/g Cr

• Treatment with an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) with no change in dosage or medication etc.

Exclusion Criteria:

• Diabetes mellitus that is neither type 1 nor type 2

• Decreased renal function mainly attributed to a non-diabetic cause

• History of renal transplantation or upcoming preemptive renal transplantation

• Confirmed mean systolic blood pressure > 160 mmHg or a confirmed mean diastolic blood pressure > 90 mmHg during the 8-week period before screening

• Hemoglobin A1c level > 10.0% during screening

• Serum albumin level ≤ 3.0 g/dL during screening

• Cardiovascular disease specified in the study protocol

• History of cardiac failure

• BNP level > 200 pg/mL during screening etc.