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) — DRUG
    Finerenone 10 or 20mg in participants with chronic kidney disease not using renin-angiotensin-system inhibitors
  • Placebo — DRUG
    Placebo 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: Finerenone
    Finerenone 10mg or 20mg, tablet (oral), once daily for approximately 6 months.
  • Placebo Comparator: Placebo
    Placebo 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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