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

Diabetic Kidney Disease Clinical Trial

Official title:

RTA 402 Phase 3 Clinical Trial (A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients With Diabetic Kidney Disease)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03550443
• Other study ID #: RTA 402-006
• Status: Terminated
• Phase: Phase 3
• Start date: May 30, 2018
• Est. completion date: July 31, 2023

Study information

• Verified date: September 2023
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1323
• Est. completion date: July 31, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Intervention

Drug:
• Bardoxolone methyl
Bardoxolone methyl 5 mg capsules
• Placebo
Capsules containing an inert placebo

Locations

Country	Name	City	State
Japan	Japan Community Health care Organization Sendai Hospital	Sendai	Miyagi

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to onset of a = 30% decrease in eGFR from baseline or ESRD		Through double-blind part completion, approximately 3 to 4 years
Secondary	Time to onset of a = 40% decrease in eGFR from baseline or ESRD		Through double-blind part completion, approximately 3 to 4 years
Secondary	Time to onset of a = 53% decrease in eGFR from baseline or ESRD		Through double-blind part completion, approximately 3 to 4 years
Secondary	Time to onset of ESRD		Through double-blind part completion, approximately 3 to 4 years
Secondary	Change in eGFR from baseline at each evaluation time point		Through double-blind part completion, approximately 3 to 4 years