FINE-START: Efficacy and Safety of Finerenone in Patients With Chronic Kidney Disease Not Using Renin-angiotensin-system Inhibitors
- Sponsor
- University Medical Center Groningen
- Study ID
- NCT07181135
- Phase
- PHASE3
- Status
- Enrolling By Invitation
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Finerenone (BAY 94-8862) — DRUGFinerenone 10 or 20mg in participants with chronic kidney disease not using renin-angiotensin-system inhibitors
- Placebo — DRUGPlacebo matching finerenone
Study Details
Study to demonstrate efficacy of finerenone when compared to placebo in reducing albuminuria in participants with chronic kidney disease (CKD) not using renin-angiotensin-system (RAS) inhibitors.
Key Dates
- Start date
- Mar 13, 2026
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 180 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: FinerenoneFinerenone 10mg or 20mg, tablet (oral), once daily for approximately 6 months.
- Placebo Comparator: PlaceboPlacebo matching Finerenone 10mg or 20mg, tablet (oral), once daily for approximately 6 months.
Primary Outcome Measure
Urinary albumin-to-creatinine ratio (UACR) [ Time Frame: Baseline upto 6 months ]
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