We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03550443
Recruitment Status : Active, not recruiting
First Posted : June 8, 2018
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Diabetic Kidney Disease Drug: Bardoxolone methyl Drug: Placebo Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1323 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Time to onset of a ≥ 30% decrease in eGFR from baseline or ESRD [ Time Frame: 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 [ Time Frame: Through double-blind part completion, approximately 3 to 4 years ]
  2. Time to onset of a ≥ 53% decrease in eGFR from baseline or ESRD [ Time Frame: Through double-blind part completion, approximately 3 to 4 years ]
  3. Time to onset of ESRD [ Time Frame: Through double-blind part completion, approximately 3 to 4 years ]
  4. Change in eGFR from baseline at each evaluation time point [ Time Frame: Through double-blind part completion, approximately 3 to 4 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550443


Locations
Layout table for location information
Japan
Japan Community Health care Organization Sendai Hospital
Sendai, Miyagi, Japan, 981-3281
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier: NCT03550443    
Other Study ID Numbers: RTA 402-006
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases