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Based on results of double-blind parts, it was determined that it would be difficult to submit a marketing authorization application for RTA 402 for diabetic kidney disease.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RTA 402(Bardoxolone methyl) | Experimental | 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. |
|
| Placebo | Placebo Comparator | Patients randomized to placebo will remain on placebo throughout the study, undergoing sham titration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bardoxolone methyl | Drug | Bardoxolone methyl 5 mg capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of a ≥ 30% decrease in eGFR from baseline or ESRD | Through double-blind part completion, approximately 3 to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of a ≥ 40% decrease in eGFR from baseline or ESRD | Through double-blind part completion, approximately 3 to 4 years | |
| Time to onset of a ≥ 53% decrease in eGFR from baseline or ESRD | Through double-blind part completion, approximately 3 to 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Japan Community Health care Organization Sendai Hospital | Sendai | Miyagi | 981-3281 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40498549 | Derived | Yoshioka K, Kaneko H, Haruyama W, Tomiyama T, Takami A, Kitayama T, Yamasaki K. Multi-Omics Reveal Antioxidant Effects of Bardoxolone Methyl in the Phase 2 Study of Bardoxolone Methyl in Patients with CKD and Type 2 Diabetes Study. Kidney360. 2025 Nov 1;6(11):1880-1889. doi: 10.34067/KID.0000000853. Epub 2025 Jun 11. |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D003920 | Diabetes Mellitus |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C445068 | bardoxolone methyl |
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Randomized double-blinded part followed by open label extension part.
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| Placebo | Drug | Capsules containing an inert placebo |
|
| Time to onset of ESRD | Through double-blind part completion, approximately 3 to 4 years |
| Change in eGFR from baseline at each evaluation time point | Through double-blind part completion, approximately 3 to 4 years |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |