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

Kyowa Kirin

Status and phase: Terminated; Phase 3

Conditions: Diabetic Kidney Disease

Treatments: Drug: Placebo; Drug: Bardoxolone methyl

Study type: Interventional

Funder types: Industry

Identifiers

NCT03550443

RTA 402-006

Details and patient eligibility

About

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.

Enrollment: 1,323 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,323 participants in 2 patient groups, including a placebo group

RTA 402(Bardoxolone methyl)

Experimental group

Description:

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.

Treatment:

Drug: Bardoxolone methyl

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo