Trials / Terminated
TerminatedNCT03550443
A Phase 3 Study of Bardoxolone Methyl in Patients With Diabetic Kidney Disease; AYAME Study
RTA 402 Phase 3 Clinical Trial (A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients With Diabetic Kidney Disease)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,323 (actual)
- Sponsor
- Kyowa Kirin Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 79 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bardoxolone methyl | Bardoxolone methyl 5 mg capsules |
| DRUG | Placebo | Capsules containing an inert placebo |
Timeline
- Start date
- 2018-05-30
- Primary completion
- 2022-11-30
- Completion
- 2023-07-31
- First posted
- 2018-06-08
- Last updated
- 2023-09-26
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03550443. Inclusion in this directory is not an endorsement.