Tests finerenone in people with chronic kidney disease not using RAS inhibitors
Tests finerenone against a placebo in adults with chronic kidney disease.
Plain-language title generated from the registry record
Registry title: FINE-START: Efficacy and Safety of Finerenone in Patients With Chronic Kidney Disease Not Using Renin-angiotensin-system Inhibitors
Key facts
- Where
- A Coruña, Badalona, Barcelona, Getafe, Madrid, Majadahonda, Pamplona, Sevilla, and Valencia, SpainSee the 11 sites
- Phase
- Phase 3
Where in Spain
- Complexo Hospitalario Universitario A CoruñaA Coruña, SpainTaking people
- Hospital Germans Trias i PujolBadalona, SpainTaking people
- Fundació Hospital Universitari Vall d'Hebron - Institut de RecercaBarcelona, SpainTaking people
- Hospital Universitario de GetafeGetafe, SpainTaking people
- Hospital Universitario de la PrincesaMadrid, SpainTaking people
- Hospital Universitario Fundación Jiménez DíazMadrid, SpainTaking people
- Hospital Universitario Puerta de Hierro de MajadahondaMajadahonda, SpainTaking people
- Clínica Universidad de navarraPamplona, SpainTaking people
- Hospital Universitario Virgen De La MacarenaSevilla, SpainTaking people
- Hospital Clinico Universitario de ValenciaValencia, SpainTaking people
- Hospital Universitario Doctor PesetValencia, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Medical Center Groningen
- Trial code
- NCT07181135EU 2025-523075-32-00
- Record updated
- 14 April 2026
- Original description
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.Read full original descriptionShow less
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
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.
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.