A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL
2/3期
已完成
NCT03019185
| 适应症 | Alport Syndrome |
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| 分期 | 2/3期 |
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| 申办方 | Biogen |
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| 状态 | 已完成 |
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| 受试者人数 | 187 人 |
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| 干预（药物） | Placebo Oral Capsule, Bardoxolone Methyl |
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| 开始日期 | 2017年3月2日 |
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| 完成日期 | 2020年10月6日 |
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| 结果公布日 | 2023年10月11日 |
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摘要
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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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。