FINE-START: Efficacy and Safety of Finerenone in Patients With Chronic Kidney Disease Not Using Renin-angiotensin-system Inhibitors

Not Applicable

Not yet recruiting

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Finerenone (BAY 94-8862); Drug: Placebo

• Registration Number: NCT07181135
• Lead Sponsor: University Medical Center Groningen

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-angiotensin-system (RAS) inhibitors. The study will enroll adults (≥18 years) with CKD defined as eGFR ≥25 and \<120 mL/min/1.73 m2, urinary albumin-to-creatinine ratio (UACR) ≥100 mg/g (11.3 mg/mmol) to \<5000 mg/g (565 mg/mmol) and documentation of elevated albuminuria or proteinuria. A total of 180 participants will be included and randomized with equal allocation (1:1) to Finerenone or placebo. Finerenone or placebo will be administered once daily for approximately 6 months. Change in UACR from baseline over 6 months will be used as a primary endpoint to demonstrate slowing of kidney disease progression. The aim of this study is 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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-09
• Study First Submitted QC: 2025-09-16
• Study First Posted: 2025-09-18
• Last Update Submitted: 2025-09-19
• Last Update Posted: 2025-09-24
• Study Start: 2025-12-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. 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.

2. Potassium level ≤5.0 mmol/L at Screening (local assessment).

3. 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 Criteria

1. Participants with an HbA1c>11%.
2. Participants with type 1 diabetes.
3. Symptomatic heart failure with reduced ejection fraction and class 1A indication for MRA treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Finerenone	Finerenone (BAY 94-8862)	Finerenone 10mg or 20mg, tablet (oral), once daily for approximately 6 months.
Placebo	Placebo	Placebo matching Finerenone 10mg or 20mg, tablet (oral), once daily for approximately 6 months.

Primary Outcome Measures

Name	Time	Method
Urinary albumin-to-creatinine ratio (UACR)	Baseline upto 6 months	Change in UACR from baseline (ratio to baseline) over 6 months

Secondary Outcome Measures

Name	Time	Method
TEAEs, TESAEs	Baseline upto 6 months	Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
Number of participants with Hyperkalemia	Baseline upto 6 months	Number of participants with Hyperkalemia (adverse event of special interest, AESI)