NCT05901831CompletedPhase 3
A study to learn how well the study treatment finerenone works and how safe it is in people with long-term decrease in the kidneys’ ability to work properly (chronic kidney disease) together with type 1 diabetes
(22267) A parallel-group, randomized, prospective, interventional, double-blind, multicenter global Phase 3 study to investigate the efficacy and safety of finerenone versus placebo, in addition to standard of care, in participants with chronic kidney disease and type 1 diabetes
Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Sept 2025
Brief summary (registry, in English)
To demonstrate that finerenone in addition to SoC is superior to placebo in reducing UACR over 6 months in participants with CKD and T1D
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 105 (actual)
- First submitted
- 29 Jun 2023
- Start date
- 27 Feb 2024
- Lead sponsor
- Bayer AG
- Diseases
- Chronic kidney disease, Type 1 diabetes
- EU CT number
- 2022-503024-27-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 105
- 23 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous assignment to study intervention during this study.
Other illness
- Participant with T2D (Type 2 diabetes).
Lab values
- Participants with current or previous (within 8 weeks prior to the Screening visit) treatment with a SGLT-2/-1 (Sodium-Glucose co-transporter-2/-1) inhibitor or GLP1 receptor agonist.
Other
- Participant with mean BP (Blood pressure) higher than 160/100 mmHg or mean systolic BP lower than 90 mmHg at the Screening visit
Who the study is looking for
- Participant must be ≥18 years of age (or the legal age of consent according to local legislation) at the time of signing the informed consent.
- Participants with T1D, i.e. T1D continuously treated with insulin, started within one year from diagnosis.
- HbA1c at Screening <10% (central assessment). Note: One reassessment is allowed for HbA1c during the Screening period in case the first measurement is missing/unreadable/invalid.
- K+ ≤ 4.8 mmol/L at Screening (local assessment)
- "Participants with a clinical diagnosis of CKD and fulfilling both the criteria (central assessment): - eGFR ≥25 and <90 mL/min/1.73 m2 using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) 2009 formula at the Screening visit - UACR ≥200 mg/g (22.6 mg/mmol) to <5000 mg/g (565 mg/mmol) at the Screening visit (geometric mean of the 3 measurements) "
- Participants on a stable (preferably without any change in the dosage for at least 4 weeks prior to the Screening visit) ACEI (Angiotensin-converting enzyme inhibitor) or ARB (Angiotensin receptor blocker) treatment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum Coordinator of this site? Confirm its status | Bad Oeynhausen | Germany | Completed |
| InnoDiab Forschung Gmbh Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Sydvestjysk Sygehus Coordinator of this site? Confirm its status | Esbjerg | Denmark | Completed |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Gistrup | Denmark | Completed |
| Steno Diabetes Center Copenhagen Coordinator of this site? Confirm its status | Herlev | Denmark | Completed |
| Region Midtjylland Coordinator of this site? Confirm its status | Herning | Denmark | Completed |
| Nordsjaellands Hospital Coordinator of this site? Confirm its status | Hilleroed | Denmark | Completed |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Completed |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Nisa Sevilla Aljarafe Coordinator of this site? Confirm its status | Castilleja De La Cuesta | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Completed |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Azienda Ospedaliera Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Completed |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Completed |
| ASL To5 Coordinator of this site? Confirm its status | Chieri | Italy | Completed |
| Universita' Degli Studi G. D'annunzio Di Chieti Coordinator of this site? Confirm its status | Chieti | Italy | Completed |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Completed |
| Azienda Sociosanitaria Territoriale Santi Paolo E Carlo Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
Related publications
- Finerenone in Type 1 Diabetes and Chronic Kidney Disease.N Engl J Med · 2026 · PMID 41780000
This page is information, not medical advice. Discuss any trial with your doctor.