A Trial of Bardoxolone Methyl in Patients With CKD at Risk of Rapid Progression (MERLIN)
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This 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.