A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL
Фаза 2/3
Завершено
NCT03019185
| Заболевание | Alport Syndrome |
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| Фаза | Фаза 2/3 |
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| Спонсор | Biogen |
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| Статус | Завершено |
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| Участники | 187 участн. |
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| Вмешательство | Placebo Oral Capsule, Bardoxolone Methyl |
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| Дата начала | 2.03.2017 |
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| Дата завершения | 6.10.2020 |
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| Публикация результатов | 11.10.2023 |
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Кратко
This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2 portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180 patients.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 12 Weeks of Treatment (Phase 2)
Baseline through 12 weeks after participant receives the first dose in the Phase 2 study · mL/min/1.73 m^2
| Phase 2 Bardoxolone Methyl | 13.37 ± 1.4111 mL/min/1.73 m^2 |
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| p-value | <0.0001 |
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| LS Mean change from baseline | 13.37 (95% CI 10.48–16.27) |
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Change From Baseline in eGFR After 48 Weeks of Treatment (Phase 3)
Baseline through 48 weeks after participant receives the first dose in the Phase 3 study · mL/min/1.73 m^2
| Phase 3 Placebo | -4.77 ± 1.248 mL/min/1.73 m^2 |
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| Phase 3 Bardoxolone Methyl | 4.71 ± 1.307 mL/min/1.73 m^2 |
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| p-value | <0.0001 |
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| LS Mean difference (Net) | 9.49 (95% CI 5.38–13.60) |
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Change From Baseline in eGFR After 100 Weeks of Treatment (Phase 3)
Baseline through 100 weeks after participant receives the first dose in the Phase 3 study · mL/min/1.73 m^2
| Phase 3 Placebo | -8.45 ± 1.478 mL/min/1.73 m^2 |
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| Phase 3 Bardoxolone Methyl | -0.81 ± 1.556 mL/min/1.73 m^2 |
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| p-value | 0.0005 |
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| LS Mean difference (Net) | 7.65 (95% CI 3.41–11.89) |
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