FINE-START: Efficacy and Safety of Finerenone in Patients With Chronic Kidney Disease Not Using Renin-angiotensin-system Inhibitors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Finerenone (BAY 94-8862), Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Parallel-group, Randomized, Prospective, Interventional, Double-blind, Multicenter Global Phase 3 Study to Investigate the Efficacy and Safety of Finerenone Versus Placebo, in Participants With Chronic Kidney Disease Not Using Renin-angiotensin-system Inhibitors
Overview
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.
Interventions
- Drug Finerenone (BAY 94-8862)
Finerenone 10 or 20mg in participants with chronic kidney disease not using renin-angiotensin-system inhibitors - Drug Placebo
Placebo matching finerenone
Primary outcome measures
- Urinary albumin-to-creatinine ratio (UACR) [Time frame: Baseline upto 6 months]
Secondary outcome measures (2)
- TEAEs, TESAEs [Time frame: Baseline upto 6 months]
- Number of participants with Hyperkalemia [Time frame: Baseline upto 6 months]
Eligibility criteria
Main Inclusion Criteria:
- 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 Criteria:
- Participants with an HbA1c>11%.
- Participants with type 1 diabetes.
- Symptomatic heart failure with reduced ejection fraction and class 1A indication for MRA treatment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 8 centers
- Hospital Universitari Germans Trias i Pujol — Barcelona
- Vall d'Hebron University Hospital — Barcelona
- Clínica Universidad de Navarra — Madrid
- Hospital Universitario de La Princesa — Madrid
- Hospital Universitario Puerta de Hierro — Madrid
- Clínica Universidad de Navarra — Pamplona
- Hospital Clinico Universitario de Valencia — Valencia
- Hospital Universitario Dr Peset — Valencia
Identifiers
NCT: NCT07181135 · 22817 · 2025-523075-32-00