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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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
Coordinator of this site? Confirm its status
Bad OeynhausenGermanyCompleted
InnoDiab Forschung Gmbh
Coordinator of this site? Confirm its status
EssenGermanyCompleted
Sydvestjysk Sygehus
Coordinator of this site? Confirm its status
EsbjergDenmarkCompleted
Aalborg University Hospital
Coordinator of this site? Confirm its status
GistrupDenmarkCompleted
Steno Diabetes Center Copenhagen
Coordinator of this site? Confirm its status
HerlevDenmarkCompleted
Region Midtjylland
Coordinator of this site? Confirm its status
HerningDenmarkCompleted
Nordsjaellands Hospital
Coordinator of this site? Confirm its status
HilleroedDenmarkCompleted
Odense University Hospital
Coordinator of this site? Confirm its status
Odense CDenmarkCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Nisa Sevilla Aljarafe
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Castilleja De La CuestaSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
Azienda Ospedaliera Papa Giovanni XXIII
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BergamoItalyCompleted
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyCompleted
ASL To5
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ChieriItalyCompleted
Universita' Degli Studi G. D'annunzio Di Chieti
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ChietiItalyCompleted
Careggi University Hospital
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FlorenceItalyCompleted
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo
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MilanItalyCompleted
Ospedale San Raffaele S.r.l.
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MilanItalyCompleted
ASST Fatebenefratelli Sacco
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MilanItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.