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Bardoxolone methyl oral capsule · MERLIN

A Trial of Bardoxolone Methyl in Patients With CKD at Risk of Rapid Progression (MERLIN)

Ensayo de BIOGEN INC. en Enfermedad renal cronica.

Más ensayos de: Enfermedad renal crónica.

Fase

Fase 2

Estado

Completado

Participantes

81

previstos

Centros

12

Fin del objetivo primario

oct 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en feb 2021.

Qué mide

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 (Baseline through 12 weeks after participant receives the first dose) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis multi-center, randomized, double-blind, placebo-controlled, Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with CKD due to multiple etiologies at risk of rapid disease progression. Approximately 70 patients will be enrolled and randomized 1:1 to either bardoxolone methyl or placebo. Patients with CKD secondary to varying etiologies will be enrolled from age 18-70 years with eGFR ≥ 20 to \< 60 mL/min/1.73 m2, and other risk factors for rapid progression of kidney disease. The maximum target dose will be determined by baseline proteinuria status. Patients with baseline urine albumin to creatinine ratio (UACR) ≤ 300 mg/g will be titrated to a maximum dose of 20 mg, and patients with baseline UACR \> 300 mg/g will be titrated to a maximum dose of 30 mg. Qualified patients will be randomized 1:1 to receive either bardoxolone methyl or placebo once daily (preferably in the morning) throughout a 12-week dosing period. Patients in the study will follow the same visit and assessment schedule. Patients will 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. Date of last dose and the end-of-treatment assessments mark the end of the treatment period. Patients will not receive study drug during a 5-week off-treatment period between Weeks 12 and 17. The off-treatment (OT) period includes 5 visits requiring various assessments to characterize eGFR from the time of study drug discontinuation through Day 35 off-treatment.

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Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04702997), actualizada en may 2025.