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Could a kidney drug for type 2 diabetes also help type 1 patients?

NCT ID NCT05901831

Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested whether finerenone, a drug already approved for kidney disease in type 2 diabetes, can also slow kidney damage in people with type 1 diabetes. 241 adults with both conditions took either finerenone or a placebo for 6 months, alongside their usual care. Researchers measured changes in urine protein levels and monitored safety, including side effects and high potassium levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
finerenone
What this could lead to
If it works, finerenone could become a new treatment option to slow kidney disease progression in people with type 1 diabetes.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. Finerenone is already approved for type 2 diabetes, so it may not work the same way for type 1 diabetes. Risks include high potassium levels.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

241 people

The number who actually took part.

Started

Feb 2024

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Type 1 diabetes (T1D), i.e. T1D continuously treated with insulin, started within one year from diagnosis. * If the onset was after age 35, documentation of the presence of one or more of the following: * Circulating T1D-associated autoantibodies * Hospitalization for diabetic ketoacidosis * Plasma C-peptide below the limit of detection with standard assay (with concurrent blood glucose \>100 mg/dl). * 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 m\^2 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. Exclusion Criteria: * Participant with T2D (Type 2 diabetes). * Participant with mean BP (Blood pressure) higher than 160/100 mmHg or mean systolic BP lower than 90 mmHg at the Screening visit * Symptomatic heart failure with reduced ejection fraction with class 1A indication for Mineralocorticoid receptor antagonists (MRAs). * 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 (Glucagon-like peptide-1) receptor agonist.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease Type 1 diabetes mellitus

Contacts and locations

Locations

  • ASST Fatebenefratelli Sacco _Ospedale Sacco - Malattie Endocrine e Diabetologia

    Milan, 20157, Italy

  • ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia

    Bergamo, 24127, Italy

  • ASST Santi Paolo e Carlo | San Paolo Hospital - Haemostasis and Thrombosis Department

    Milan, 20142, Italy

  • Accellacare - Wilmington

    Wilmington, North Carolina, 28401, United States

  • AdventHealth Translational Research Institute

    Orlando, Florida, 32804, United States

  • Affiliated Hospital of Jiangsu University

    JiangSu, Jiangsu, 212001, China

  • Alberta Diabetes Institute - Clinical Research Unit (CRU)

    Edmonton, Alberta, T6G 2E1, Canada

  • Asan Medical Center - Oncology Department

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Endocrinologia e prevenzione e cura del diabete

    Bologna, Emilia-Romagna, 40138, Italy

  • Azienda Sanitaria Locale di Chieri | TO5 - SC Diabetologia Territoriale

    Chieri, 10023, Italy

  • Barts Health NHS Trust - Royal London Hospital - Nephrology

    London, E1 1BB, United Kingdom

  • Capital Region | Nordsjaellands Hospital - Hillerod - Endocrinology Ambulatory Research Unit

    Hillerød, 3400, Denmark

  • Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant

    Cardiff, CF14 4XW, United Kingdom

  • Careggi University Hospital - Diabetologia e Malattie del Metabolismo

    Florence, Tuscany, 50134, Italy

  • Central Hospital of Minhang District, Shanghai

    Shanghai, 201100, China

  • Centre de Recherche Clinique de Laval

    Laval, Quebec, H7T 2P5, Canada

  • Cleveland Clinic - Main Campus

    Cleveland, Ohio, 44195, United States

  • Consano Clinical Research, LLC.

    San Antonio, Texas, 79231, United States

  • Diabetes & Metabolism Associates

    Metairie, Louisiana, 70006, United States

  • EVMS Strelitz Diabetes Center

    Norfolk, Virginia, 23510, United States

  • Elixia Central Florida

    Orlando, Florida, 32806, United States

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Diabetologia

    Rome, Lazio, 00168, Italy

  • Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition

    A Coruña, A Coruña, 15006, Spain

  • Grady Memorial Hospital - Endocrinology

    Atlanta, Georgia, 30303, United States

  • Hanson Clinical Research Center, Inc.

    Port Charlotte, Florida, 33952, United States

  • Hospital Clinic de Barcelona | Instituto Clinic de Enfermedades Digestivas y Metabolicas - Endocrinologia y Nutricion

    Barcelona, 08036, Spain

  • Hospital Gregorio Maranon | Endocrinology Department

    Madrid, 28007, Spain

  • Hospital Nisa Sevilla Aljarafe - Endocrinologia

    Castilleja de la Cuesta, Sevilla, 41950, Spain

  • Hospital Universitario Puerta De Hierro De Majadahonda - Endocrinologia

    Majadahonda, 28222, Spain

  • Hospital Universitario Virgen De La Victoria - Endocrinologia

    Málaga, 29010, Spain

  • Hospital of South West Jutland | Department of Endocrinology Research

    Esbjerg, 6700, Denmark

  • Huai'an First People's Hospital, Nanjing Medical University

    Huai'an, 223300, China

  • IRCCS Ospedale San Raffaele | Diabetologia Department - Cardio-Metabolic and Clinica Trials Unit

    Milan, 20132, Italy

  • InnoDiab Forschung GmbH

    Essen, North Rhine-Westphalia, 45136, Germany

  • Jedidiah Clinical Research

    Tampa, Florida, 33619, United States

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215, United States

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • MU Health Care - University Hospital - Endocrinology

    Columbia, Missouri, 65212, United States

  • Manchester University NHS Foundation Trust | Wythenshawe Hospital - Clinical Research Facility

    Manchester, M23 9LT, United Kingdom

  • McGill University Health Centre (MUHC) - Research Institute (RI) - McConnell Centre for Innovative Medicine (CIM)

    Montreal, Quebec, H4A 3J1, Canada

  • MedStar Health Research Institute

    Hyattsville, Maryland, 20782, United States

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401, United States

  • NHS Greater Glasgow and Clyde (NHSGGC) - Glasgow Royal Infirmary (GRI)

    Glasgow, G4 0SF, United Kingdom

  • Nanjing Medical University (NMU) - The Second Affiliated Hospital

    Nanjing, 210011, China

  • North Bristol NHS Trust | Southmead Hospital - Clinical Research Centre

    Bristol, BS10 5NB, United Kingdom

  • Northwestern University | Feinberg School of Medicine - Division of Endocrinology, Metabolism and Molecular Medicine

    Chicago, Illinois, 60611, United States

  • OHSU Physicians Pavillion - Endocrinology

    Portland, Oregon, 97239, United States

  • Odense University Hospital | Odense - Endocrinology Department

    Odense, 5000, Denmark

  • Peking University People's Hospital

    Beijing, 100032, China

  • Physicians East, P.A.- W. H. Smith - Endocrinology

    Greenville, North Carolina, 27834, United States

  • Preventive Intervention Center - Endocrinology

    Iowa City, Iowa, 52202, United States

  • Providence Medical Research Center

    Spokane Valley, Washington, 99204, United States

  • Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department

    Herning, DK-7400, Denmark

  • Region Nordjylland | Steno Diabetes Center Nordjylland - Endocrinology Department

    Gistrup, 9260, Denmark

  • Richmond Road Diagnostic and Treatment Centre - Clinical Trials Unit(RRDTC)

    Calgary, Alberta, T2T 5C7, Canada

  • Ruhr-Universitaet Bochum - Herz und Diabeteszentrum NRW (Heart and Diabetes Center)

    Bad Oeynhausen, 32545, Germany

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 3080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

  • Shanghai Jiao Tong University (SJTU) - Shanghai General Hospital (Shanghai First People's Hospital) - Northern Location

    Shanghai, 200080, China

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032, China

  • Southern Medical University - Nanfang Hospital (Southern Hospital)

    Guangzhou, 510515, China

  • Southwest Kidney Institute, PLC - Suprise

    Surprise, Arizona, 85374, United States

  • Stanford Endocrinology Clinic

    Stanford, California, 94305, United States

  • Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department

    Herlev, 2730, Denmark

  • The 4th Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001, China

  • The Central Hospital of Wuhan, Tongji Medl Collg Huazhong...

    Wuhan, Hubei, 430014, China

  • Toronto General Hospital - University Health Network, Renal Physiology laboratory

    Toronto, Ontario, M5G 2C4, Canada

  • Touro University California - Metabolic Research Center

    Vallejo, California, 94592, United States

  • UChicago Medicine Kovler Diabetes Center

    Chicago, Illinois, 60637, United States

  • UHealth Diabetes Research Center

    Miami, Florida, 33136, United States

  • UNC Endocrinology, Diabetes, and Obesity Clinical Research Unit

    Chapel Hill, North Carolina, 27514, United States

  • UT Health San Antonio - Medical Arts & Research Center - Endocrinology

    San Antonio, Texas, 78229, United States

  • University Hospitals of Derby and Burton NHS Foundation Trust | Royal Derby Hospital - Renal Research

    Derby, DE22 3NE, United Kingdom

  • Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia

    Chieti, 66100, Italy

  • Walsall Healthcare NHS Trust | Manor Hospital - Nephrology

    Walsall, WS2 9PS, United Kingdom

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110-1010, United States

  • Wichita Nephrology Group Pa

    Wichita, Kansas, 67214, United States

  • Zhongshan Hospital Fudan University, Qingpu Branch

    Shanghai, 201700, China

  • Zhongshan People's Hospital

    Zhongshan, Guangdong, 528499, China

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