Status:
NOT_YET_RECRUITING
FINE-START: Efficacy and Safety of Finerenone in Patients With Chronic Kidney Disease Not Using Renin-angiotensin-system Inhibitors
Lead Sponsor:
University Medical Center Groningen
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
FINE-START is a multicenter, international, randomized, placebo-controlled, double blind parallel-group Phase 3 study in adult participants with chronic kidney disease (CKD) not using renin-angiotensi...
Eligibility Criteria
Inclusion
- Main
- Adults (≥18 years) with Chronic Kidney Disease defined as:
- eGFR ≥25 and \<120 mL/min/1.73 m2 using CKD-EPI 2009 formula at the Screening visit.
- UACR ≥100 mg/g (11.3 mg/mmol) to \<5000 mg/g (565 mg/mmol) at the Screening visit (geometric mean of the 3 measurements) and documentation of elevated albuminuria or proteinuria.
- Potassium level ≤5.0 mmol/L at Screening (local assessment).
- No current or previous (within 8 weeks prior to the Screening visit) treatment with RAS inhibition (ACEi, ARB, or Renin inhibitor (e.g. Aliskiren)).
- Main
Exclusion
- Participants with an HbA1c\>11%.
- Participants with type 1 diabetes.
- Symptomatic heart failure with reduced ejection fraction and class 1A indication for MRA treatment.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07181135
Start Date
December 1 2025
End Date
December 31 2027
Last Update
September 24 2025
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