NCT07181135Enrolling by invitationPhase 3
FINE-START: Efficacy and Safety of Finerenone in Patients With Chronic Kidney Disease Not Using Renin-angiotensin-system Inhibitors
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
Source: ClinicalTrials.gov · Last updated 14 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 9 Sept 2025
- Start date
- 13 Mar 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Chronic kidney disease
- NCT number
- NCT07181135
- EU CT number
- 2025-523075-32-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 180
- From 13 Mar 2026 to the primary completion date, 31 Dec 2027
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario de Getafe Coordinator of this site? Confirm its status | Getafe | Spain | Recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Universitario Doctor Peset Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.