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

Sponsor
Kyowa Kirin Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03550443
Collaborator
(none)
1,323
Enrollment
1
Location
2
Arms
77.1
Anticipated Duration (Months)
17.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bardoxolone methyl
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1323 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized double-blinded part followed by open label extension part.Randomized double-blinded part followed by open label extension part.
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
RTA 402 Phase 3 Clinical Trial (A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients With Diabetic Kidney Disease)
Actual Study Start Date :
May 30, 2018
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Bardoxolone methyl
Bardoxolone methyl 5 mg capsules
Other Names:
  • RTA 402

    		•
    Placebo Comparator: Placebo

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

    Drug: Placebo
    Capsules containing an inert placebo

    Outcome Measures

    Primary Outcome Measures

    1. Time to onset of a ≥ 30% decrease in eGFR from baseline or ESRD [Through double-blind part completion, approximately 3 to 4 years]

    Secondary Outcome Measures

    1. Time to onset of a ≥ 40% decrease in eGFR from baseline or ESRD [Through double-blind part completion, approximately 3 to 4 years]

    2. Time to onset of a ≥ 53% decrease in eGFR from baseline or ESRD [Through double-blind part completion, approximately 3 to 4 years]

    3. Time to onset of ESRD [Through double-blind part completion, approximately 3 to 4 years]

    4. Change in eGFR from baseline at each evaluation time point [Through double-blind part completion, approximately 3 to 4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Japan Community Health care Organization Sendai Hospital Sendai Miyagi Japan 981-3281

    Sponsors and Collaborators

    • Kyowa Kirin Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kyowa Kirin Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03550443
    Other Study ID Numbers:
    • RTA 402-006
    First Posted:
    Jun 8, 2018
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Kyowa Kirin Co., Ltd.
    Bardoxolone Methyl
    Diabetic Kidney Disease
    Diabetes Mellitus
    Kidney Diseases
    Additional relevant MeSH terms:
    Kidney Diseases
    Diabetic Nephropathies

    Study Results

    No Results Posted as of Jun 30, 2022