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Also known as RTA 402 (Bardoxolone Methyl), Bardoxolone methyl oral capsule, Bardoxolone methyl capsules, Bardoxolone methyl
RTA 402 · 8 trials · 25 indications
To assess the change in eGFR from baseline to week 12. eGFR is a measure of kidney function assessed through blood/serum. Higher eGFRs represent better/improved kidney function. Lower eGFRs represent poorer/decreased kidney function.
To assess the change in eGFR from baseline to week 12 (Phase 2). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
To assess the change in eGFR from baseline to week 48 (Phase 3). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
To assess the change in eGFR from baseline to week 100 (Phase 3). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Overall treatment effect in exercise capacity, as measured by the total distance walked in 6 minutes (6MWD) mean change from baseline though Week 16. A lower 6MWD reflects greater severity thus, a positive change from baseline suggests an improvement.
| Arm | Type | Description |
|---|---|---|
| Bardoxolone methyl | EXPERIMENTAL | Patients randomized to receive bardoxolone methyl capsules orally once daily for 12 weeks at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) Patients will be scheduled to be assessed during treatment at Day 1, Weeks 1, 2, 4, 6, 8, and 12 and by telephone contact on Days 3, 10, 21, 31, 35, and 45. Patients will not receive any drug during a 5-week off-treatment period between Weeks 12 and 17. Patients will be assessed on Day 3 off-treatment (OT), Day 7 OT, Day 14 OT, Day 21 OT, Day 28 OT, and Day 35 OT. The OT day corresponds to days after last dose. Patients will be assessed at and end-of-study (EOS) visit on Week 17. |
| Placebo | PLACEBO_COMPARATOR | Patients who received placebo, once-daily, orally, remained on placebo throughout the study duration of 12 weeks and followed the same titration to maintain the blind, Patients will be scheduled to be assessed during treatment at Day 1, Weeks 1, 2, 4, 6, 8, and 12 and by telephone contact on Days 3, 10, 21, 31, 35, and 45. Patients will not receive any drug during a 5-week off-treatment period between Weeks 12 and 17. Patients will be assessed on Day 3 off-treatment (OT), Day 7 OT, Day 14 OT, Day 21 OT, Day 28 OT, and Day 35 OT. The OT day corresponds to days after last dose. Patients will be assessed at and end-of-study (EOS) visit on Week 17. |
| Bardoxolone Methyl - ADPKD | EXPERIMENTAL | Participants with autosomal polycystic kidney disease (ADPKD) will receive bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily. |
| Bardoxolone Methyl - IgAN | EXPERIMENTAL | Participants with IgA nephropathy (IgAN) will receive bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily. |
| Bardoxolone Methyl - T1D | EXPERIMENTAL | Participants with Type 1 diabetes (T1D) will receive bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily. |
| Bardoxolone Methyl - FSGS | EXPERIMENTAL | Participants with focal segmental glomerulosclerosis (FSGS) will receive bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily. |
| Phase 2 Bardoxolone Methyl | EXPERIMENTAL | Patients in the Phase 2 cohort will receive bardoxolone methyl throughout the study. Patients with baseline ACR ≤ 300 mg/g will be titrated to a maximum dose of 20 mg, and patients with baseline ACR \> 300 mg/g will be titrated to a maximum dose of 30 mg. Adult patients (≥ 18 years of age) receiving bardoxolone methyl will start with once-daily dosing at 5 mg and will dose-escalate to 10 mg at Week 2, to 20 mg at Week 4, and then to 30 mg at Week 6 (only if baseline ACR \>300 mg/g) unless contraindicated clinically and approved by the medical monitor. Patients under the age of 18 receiving bardoxolone methyl will start 5 mg every other day during the first week and begin once-daily dosing with 5 mg during the second week of the study, and then continue with once-daily dosing following the same aforementioned dose titration scheme based on baseline ACR at Weeks 2, 4, and 6. |
| Phase 3 Bardoxolone Methyl | ACTIVE_COMPARATOR | Patients with baseline ACR ≤ 300 mg/g will be titrated to a maximum dose of 20 mg, and patients with baseline ACR \> 300 mg/g will be titrated to a maximum dose of 30 mg. Adult patients (≥ 18 years of age) receiving bardoxolone methyl will start with once-daily dosing at 5 mg and will dose-escalate to 10 mg at Week 2, to 20 mg at Week 4, and then to 30 mg at Week 6 (only if baseline ACR \>300 mg/g) unless contraindicated clinically and approved by the medical monitor. Patients under the age of 18 receiving bardoxolone methyl will start 5 mg every other day during the first week and begin once-daily dosing with 5 mg during the second week of the study, and then continue with once-daily dosing following the same aforementioned dose titration scheme based on baseline ACR at Weeks 2, 4, and 6. |
| Phase 3 Placebo | PLACEBO_COMPARATOR | Patients randomized to placebo will remain on placebo throughout the study, undergoing sham titration. |
| Part 1 Dose-Ranging Bardoxolone methyl 2.5 mg/Part 2: Open-Label | EXPERIMENTAL | Participants received bardoxolone methyl 2.5 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 2.5 mg once-daily in Part 2 (Week 16 and onwards) |
| Part 1: Dose-Ranging Bardoxolone methyl 5 mg/Part 2: Open-Label | EXPERIMENTAL | Participants received bardoxolone methyl 5 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 5 mg once-daily in Part 2 (Week 16 and onwards) |
| Part 1: Dose-Ranging Bardoxolone methyl 10 mg/Part 2: Open-Label | EXPERIMENTAL | Participants received bardoxolone methyl 10 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 10 mg once-daily in Part 2 (Week 16 and onwards) |
| Part 1: Dose-Ranging Bardoxolone methyl 20 mg/Part 2: Open-Label | EXPERIMENTAL | Participants received bardoxolone methyl 20 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 20 mg once-daily in Part 2 (Week 16 and onwards) |
| Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone methyl 2.5 mg | PLACEBO_COMPARATOR | Participants received bardoxolone methyl 2.5 mg matching placebo capsules once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 received bardoxolone methyl 2.5 mg once-daily in Part 2 (Week 16 and onwards) |
| Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone methyl 5 mg | PLACEBO_COMPARATOR | Participants received bardoxolone methyl 5 mg matching placebo capsules once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 received bardoxolone methyl 5 mg once-daily in Part 2 (Week 16 and onwards) |
| Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone methyl 10 mg | PLACEBO_COMPARATOR | Participants received bardoxolone methyl 10 mg matching placebo capsules once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 received bardoxolone methyl 10 mg once-daily in Part 2 (Week 16 and onwards) |
| Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone methyl 20 mg | PLACEBO_COMPARATOR | Participants received bardoxolone methyl 20 mg matching placebo capsules once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 received bardoxolone methyl 20 mg once-daily in Part 2 (Week 16 and onwards) |
| Part 1: Dose Titration: Bardoxolone methyl 10 mg/Part 2: Bardoxolone methyl 10 mg | EXPERIMENTAL | Participants in Part 1 started with bardoxolone methyl 5 mg once-daily from Day 1 and escalated to bardoxolone methyl 10 mg once-daily starting at Week 4 thru Week 16. Participants who continued to Part 2 continued to receive the same bardoxolone methyl dose once-daily in Part 2 (Week 16 and onwards) |
| Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone methyl 10 mg | PLACEBO_COMPARATOR | Participants in Part 1 received Placebo once-daily from Day 1 thru Week 16. Participants who continued to Part 2 initially received bardoxolone methyl 5 mg once-daily from Week 16 thru Week 20 and bardoxolone methyl 10 mg from week 20 onwards |
| Bardoxolone methyl: 5 mg | EXPERIMENTAL | - |
| Bardoxolone methyl: 10 mg | EXPERIMENTAL | - |
| Bardoxolone methyl: 15 mg | EXPERIMENTAL | - |
| Bardoxolone methyl: 30 mg | EXPERIMENTAL | - |
| Bardoxolone methyl: 2.5 mg | EXPERIMENTAL | - |
| Bardoxolone Methyl (RTA 402): 75mg | EXPERIMENTAL | - |
| Bardoxolone Methyl (RTA 402): 150mg | EXPERIMENTAL | - |
| Bardoxolone Methyl (RTA 402): 25mg | EXPERIMENTAL | - |
| 25 mg | EXPERIMENTAL | 25 mg RTA 402 (Bardoxolone methyl)/Stratum 1 |
| 75 mg | EXPERIMENTAL | 75 mg RTA 402 (Bardoxolone methyl)/Stratum 1 |
| 150 mg | EXPERIMENTAL | 150 mg RTA 402 (Bardoxolone methyl)/Stratum 1 |
| 25/75 mg | EXPERIMENTAL | 25 mg -\> 75 mg RTA 402 (Bardoxolone methyl)/Stratum 2 |
| Bardoxolone methyl capsules | EXPERIMENTAL | Bardoxolone methyl to be taken orally for 21 consecutive days, once a day, in the morning prior to food intake. Patients to continue to receive treatment for the first 21 days of each 28-day cycle until they experience intolerable toxicity, show evidence of disease progression, or receive a maximum of 18 cycles (18 months). |
| Name | Type | Description |
|---|---|---|
| Bardoxolone methyl oral capsule | DRUG | Bardoxolone methyl capsules dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status |
| Placebo oral capsule | DRUG | Capsule containing an inert placebo |
| Bardoxolone methyl capsules | DRUG | Bardoxolone 5 mg capsules |
| Bardoxolone Methyl | DRUG | Bardoxolone methyl dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status. |
| Placebo | DRUG | - |
| Bardoxolone methyl (amorphous dispersion) | DRUG | Oral, once daily |
| Bardoxolone Methyl (RTA 402) | DRUG | Oral, Once Daily |
| RTA 402 (Bardoxolone Methyl) | DRUG | Stratum 1: 25, 75, 150mg/day, orally, 28 consecutive days Stratum 2: 25 mg/day, orally, 28 consecutive days followed by 75 mg/day, orally, 28 consecutive days |
Inclusion Criteria: * Diagnosis of CKD with screening eGFR (average of Screen A and Screen B eGFR values) ≥ 20 to \< 60 mL/min/1.73 m2 * Patient must meet at least one of the following criteria: 1. UACR ≥ 300 mg/g; OR 2. eGFR decline at a rate of ≥ 4 mL/min/1.73 m2 in prior year; OR 3. Hemat...
Top 3 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | ALN-ANG3, Evinacumab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | Atrasentan |
| ProKidney Corp. Class A | PROK | 2 | - | Rilparencel |
RTA 402 is an investigational small molecule being studied for the treatment of diabetic nephropathy, a kidney complication of diabetes. It has been evaluated in a Phase 2 clinical trial in patients with this condition. RTA 402 is not approved for commercial use and remains in clinical development.
RTA 402 is being developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen is the sponsor of the clinical program evaluating RTA 402 in diabetic nephropathy.
RTA 402 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The program has studied the drug in patients with diabetic nephropathy.
RTA 402 has been studied in one completed Phase 2 trial, NCT00664027, titled a Phase IIa trial to determine the effects of bardoxolone methyl on renal function in patients with diabetic nephropathy. The trial enrolled 80 patients in the United States and was randomized and controlled.
Yes, RTA 402 is also known as bardoxolone methyl. The two names refer to the same investigational small molecule, and the Phase 2 diabetic nephropathy trial is listed under the bardoxolone methyl name.
The completed Phase 2 trial of RTA 402, NCT00664027, enrolled 80 patients. Participants were 18 years or older, of all sexes, and the study was conducted in the United States. It was a randomized, controlled trial in diabetic nephropathy.