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NCT04702997 · ClinicalTrials.gov registry record · Phase 2
A Trial of Bardoxolone Methyl in Patients With CKD at Risk of Rapid Progression (MERLIN)
A Phase 2 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
NCT04702997 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 81 participants.
The verdict
NCT04702997, a Phase 2 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo oral capsule
- DRUG Bardoxolone methyl oral capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2021-02-09 |
| Est. Completion | 2021-11-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04702997
The ClinicalTrials.gov registry entry for NCT04702997 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT04702997 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04702997 about?
NCT04702997 is a clinical study titled "A Trial of Bardoxolone Methyl in Patients With CKD at Risk of Rapid Progression (MERLIN)". 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 random...
What is the current status of trial NCT04702997?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2021-02-09. Estimated completion is 2021-11-23.
What interventions are being tested in trial NCT04702997?
The interventions under investigation include: Placebo oral capsule (DRUG), Bardoxolone methyl oral capsule (DRUG).
Who is sponsoring clinical trial NCT04702997?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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