A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL

2/3상 완료 NCT03019185

대상 질환	Alport Syndrome
임상 단계	2/3상
스폰서	Biogen
상태	완료
참여자 수	187 명
중재(약물)	Placebo Oral Capsule, Bardoxolone Methyl
시작일	2017년 3월 2일
완료일	2020년 10월 6일
결과 공개일	2023년 10월 11일

요약

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

p-value	<0.0001
LS Mean change from baseline	13.37 (95% CI 10.48–16.27)

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
Phase 3 Bardoxolone Methyl	4.71 ± 1.307 mL/min/1.73 m^2

p-value	<0.0001
LS Mean difference (Net)	9.49 (95% CI 5.38–13.60)

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
Phase 3 Bardoxolone Methyl	-0.81 ± 1.556 mL/min/1.73 m^2

p-value	0.0005
LS Mean difference (Net)	7.65 (95% CI 3.41–11.89)

BENITIONS에서 보기 ClinicalTrials.gov 원문 보기

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