Status:
COMPLETED
A Trial of Bardoxolone Methyl in Patients With CKD at Risk of Rapid Progression (MERLIN)
Lead Sponsor:
Biogen
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 et...
Eligibility Criteria
Inclusion
- Diagnosis of CKD with screening eGFR (average of Screen A and Screen B eGFR values) ≥ 20 to \< 60 mL/min/1.73 m2
- Patient must meet at least one of the following criteria:
- UACR ≥ 300 mg/g; OR
- eGFR decline at a rate of ≥ 4 mL/min/1.73 m2 in prior year; OR
- Hematuria defined as \> 5-10 red blood cells (RBCs) per high power field (HPF, manual method), or documented history of positive urinary dipstick for blood in prior year, or macroscopic hematuria in prior 3 years;
- Systolic blood pressure ≤ 150 mmHg and diastolic blood pressure ≤ 90 mmHg at Screen A visit after a period of rest (≥ 5 minutes);
- Treatment with an angiotensin-converting enzyme inhibitor (ACEi) and/or an angiotensin II receptor blocker (ARB) at the maximally tolerated labeled daily dose for at least 6 weeks prior to the Screen A visit and with no anticipated changes to dose(s) during study participation.
- Able to swallow capsules -
Exclusion
- Prior exposure to bardoxolone methyl;
- CKD secondary to or associated with any of the following:
- History of rapidly progressive glomerulonephritis (RPGN)
- Glomerulonephritis requiring immunosuppression in the last 6 months prior to Screen A;
- Concomitant use of tolvaptan.
- Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to Day 1 or anticipated need for immunosuppression during the study;
- Patients currently taking a sodium/glucose cotransporter-2 inhibitor (SGLT2i), requiring dose adjustments within 12 weeks prior to Day 1 or if dose is anticipated to change during study participation;
- B-type natriuretic peptide (BNP) level \> 200 pg/mL at Screen A visit;
- Uncontrolled diabetes (HbA1c \> 11.0%) at Screen A visit;
- Serum albumin \< 3 g/dL at Screen A visit;
- Kidney or any other solid organ transplant recipient or a planned transplant during the study;
- Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or during Screening;
- History of clinically significant cardiac disease;
- Systolic blood pressure \< 90 mmHg at Screen A visit after a period of rest;
- Body mass index \< 18.5 kg/m2 at the Screen A visit;
- History of malignancy within 5 years prior to Screen A visit, with the exception of localized skin or cervical carcinomas;
- Coronavirus disease 2019 (COVID-19) diagnosis within 3 months prior to Screen A or have ever required COVID-19 related hospitalization;
- Participation in other interventional clinical studies within 3 months (or if relevant 5 half-lives of that study medication, whichever is the longer) prior to Screen B;
- Unwilling to practice acceptable methods of birth control;
- Women who are pregnant or breastfeeding.
Key Trial Info
Start Date :
February 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2021
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT04702997
Start Date
February 9 2021
End Date
November 23 2021
Last Update
June 3 2025
Active Locations (12)
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1
California Institute of Renal Research
La Mesa, California, United States, 91942
2
Western Nephrology
Arvada, Colorado, United States, 80002
3
Colorado Kidney Care
Denver, Colorado, United States, 80230
4
Boise Kidney & Hypertension, PLLC
Nampa, Idaho, United States, 83687