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RTA 402 Phase 3 Clinical Trial (A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients With Diabetic Kidney Disease)
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.
Age
20 - 79 years
Sex
ALL
Healthy Volunteers
No
Japan Community Health care Organization Sendai Hospital
Sendai, Miyagi, Japan
Start Date
May 30, 2018
Primary Completion Date
November 30, 2022
Completion Date
July 31, 2023
Last Updated
September 26, 2023
1,323
ACTUAL participants
Bardoxolone methyl
DRUG
Placebo
DRUG
Lead Sponsor
Kyowa Kirin Co., Ltd.
NCT07271186
NCT06600412
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05822609