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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel-group, randomized, prospective, interventional, double-blind study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Finerenone

Finerenone 10mg or 20mg, tablet (oral), once daily for approximately 6 months.

Group Type EXPERIMENTAL

Finerenone (BAY 94-8862)

Intervention Type DRUG

Finerenone 10 or 20mg in participants with chronic kidney disease not using renin-angiotensin-system inhibitors

Placebo

Placebo matching Finerenone 10mg or 20mg, tablet (oral), once daily for approximately 6 months.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching finerenone

Interventions

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Finerenone (BAY 94-8862)

Finerenone 10 or 20mg in participants with chronic kidney disease not using renin-angiotensin-system inhibitors

Intervention Type DRUG

Placebo

Placebo matching finerenone

Intervention Type DRUG

Eligibility Criteria

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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)).

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No