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

NCT ID: NCT03550443

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-30
• Study Completion Date: 2023-07-31

Brief 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.

Conditions

Diabetic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

RTA 402(Bardoxolone methyl)

Patients will receive multiple oral doses of bardoxolone methyl once daily. The starting dose of bardoxolone methyl will be 5 mg. The maximum dose will be 15 mg, and the dose will be increased by 5 mg.

Group Type: EXPERIMENTAL

Bardoxolone methyl

Intervention Type: DRUG

Bardoxolone methyl 5 mg capsules

Placebo

Patients randomized to placebo will remain on placebo throughout the study, undergoing sham titration.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Capsules containing an inert placebo

Interventions

Bardoxolone methyl

Bardoxolone methyl 5 mg capsules

Intervention Type: DRUG

Placebo

Capsules containing an inert placebo

Intervention Type: DRUG

Other Intervention Names

RTA 402

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Japan Community Health care Organization Sendai Hospital

Sendai, Miyagi, Japan

Countries

Japan

Other Identifiers

RTA 402-006

Identifier Type: -

Identifier Source: org_study_id