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Chronic Kidney DiseasePhase 3FINE-ONENCT05901831

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

A Phase 3 study testing Finerenone in people with Chronic Kidney Disease and Type 1 Diabetes Mellitus, run by Bayer at 79 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 1 diabetes. In people with type 1 diabetes, the body does not make enough of a hormone called insulin, resulting in high blood sugar levels that can… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Finerenone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
242 participants
Where
79 sitesin 9 countries
Study dates
26 Feb 2024to 15 Sep 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 13Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

79 sites in 9 countries.

79 sites in 9 countries

United States28 sites

  • Grady Memorial Hospital - Endocrinology

    Atlanta, Georgia, 30303

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • UNC Endocrinology, Diabetes, and Obesity Clinical Research Unit

    Chapel Hill, North Carolina, 27514

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

    Chicago, Illinois, 60611

  • UChicago Medicine Kovler Diabetes Center

    Chicago, Illinois, 60637

  • Cleveland Clinic - Main Campus - Endocrinology

    Cleveland, Ohio, 44195

  • MU Health Care - University Hospital - Endocrinology

    Columbia, Missouri, 65212

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

    Greenville, North Carolina, 27834

  • MedStar Health Research Institute

    Hyattsville, Maryland, 20782

  • Preventive Intervention Center - Endocrinology

    Iowa City, Iowa, 52202

  • Omega Clinical Research - Metairie

    Metairie, Louisiana, 70006

  • UHealth Diabetes Research Center - Miami

    Miami, Florida, 33136

  • EVMS Strelitz Diabetes Center

    Norfolk, Virginia, 23510

  • AdventHealth Translational Research Institute

    Orlando, Florida, 32804

  • CTR Oakwater, LLC

    Orlando, Florida, 32806

  • Hanson Clinical Research Center, Inc.

    Port Charlotte, Florida, 33952

  • OHSU Physicians Pavillion - Endocrinology

    Portland, Oregon, 97239

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

    San Antonio, Texas, 78229

  • Consano Clinical Research, LLC.

    San Antonio, Texas, 79231

  • Providence Medical Research Center

    Spokane Valley, Washington, 99204

  • Center for Advanced Medicine - Diabetes Center

    St Louis, Missouri, 63110

  • Stanford Endocrinology Clinic

    Stanford, California, 94305

  • Southwest Kidney Institute, PLC - Suprise

    Surprise, Arizona, 85374

  • Jedidiah Clinical Research

    Tampa, Florida, 33619

  • Touro University California - Metabolic Research Center

    Vallejo, California, 94592

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401

  • Wichita Nephrology Group, PA

    Wichita, Kansas, 67214

  • Accellacare - Wilmington

    Wilmington, North Carolina, 28401

Other trials in United States

China12 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Southern Medical University - Nanfang Hospital (Southern Hospital)

    Guangzhou, Guangdong, 510515

  • The 4th Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

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

    Huai'an, Jiangsu, 223300

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

    Nanjing, Jiangsu, 210011

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

    Shanghai, Shanghai Municipality, 200080

  • Central Hospital of Minhang District, Shanghai

    Shanghai, Shanghai Municipality, 201199

  • Zhongshan Hospital Fudan University, Qingpu Branch

    Shanghai, Shanghai Municipality, 201700

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032

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

    Wuhan, Hubei, 430014

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212001

  • Zhongshan People's Hospital

    Zhongshan, Guangdong, 528499

Other trials in China

Italy9 sites

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

    Bergamo, 24127

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

    Bologna, 40138

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

    Chieri, 10023

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

    Chieti, 66100

  • Careggi University Hospital - Diabetologia e Malattie del Metabolismo

    Florence, 50134

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

    Milan, 20132

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

    Milan, 20142

  • ASST Fatebenefratelli Sacco _Ospedale Sacco - Malattie Endocrine e Diabetologia

    Milan, 20157

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Diabetologia

    Roma, 00168

Other trials in Italy

United Kingdom7 sites

  • Southmead Hospital | Clinical Research Centre

    Bristol, Bristol, BS10 5NB

  • University Hospital of Wales | Nephrology and Transplant

    Cardiff, Wales, CF14 4XW

  • Royal Derby Hospital | Renal Research

    Derby, Derbyshire, DE22 3NE

  • Glasgow Royal Infirmary | Renal Unit

    Glasgow, Scotland, G4 0SF

  • Royal London Hospital | Nephrology

    London, Greater London, E1 1BB

  • Wythenshawe Hospital | Clinical Research Facility

    Manchester, Greater Manchester, M23 9LT

  • Manor Hospital | Nephrology

    Walsall, West Midlands, WS2 9PS

Other trials in United Kingdom

Denmark6 sites

  • Hospital of South West Jutland | Department of Endocrinology Research

    Esbjerg, Region of Southern Denmark / Region Syddanmark, 6700

  • Region Nordjylland | Steno Diabetes Center Nordjylland - Endocrinology Department

    Gistrup, North Denmark Region / Region Nordjylland, 9260

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

    Herlev, Capital Region / Region Hovedstaden, 2730

  • Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department

    Herning, Central Denmark Region / Region Midtjylland, 7400

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

    Hillerød, Capital Region / Region Hovedstaden, 3400

  • Odense University Hospital | Odense - Endocrinology Department

    Odense, Region of Southern Denmark / Region Syddanmark, 5000

Other trials in Denmark

Spain6 sites

  • Complexo Hospitalario Universitario A Coruna | Endocrinologia

    A Coruña, A Coruña, 15006

  • Hospital Clinic De Barcelona | Endocrinologia

    Barcelona, Barcelona, 08036

  • Hospital Nisa Sevilla Aljarafe | Endocrinologia

    Castilleja de la Cuesta, Sevilla, 41950

  • Hospital General Universitario Gregorio Maranon | Endocrinologia

    Madrid, Madrid, 28007

  • Hospital Universitario Puerta De Hierro De Majadahonda | Endocrinologia

    Majadahonda, Madrid, 28222

  • Hospital Universitario Virgen De La Victoria | Endocrinologia

    Málaga, Málaga, 29010

Other trials in Spain

Canada5 sites

  • Richmond Road Diagnostic and Treatment Centre | Clinical Trials Unit

    Calgary, Alberta, T2T 5C7

  • Alberta Diabetes Institute | Clinical Research Unit (CRU)

    Edmonton, Alberta, T6G 2E1

  • Research Institute of the McGill University Health Centre | McConnell Centre for Innovative Medicine

    Montreal, Quebec, H4A 3J1

  • Centre hospitalier universitaire de Québec (CHUQ) | Cardiology

    Québec, Quebec, G1R 2J6

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

    Toronto, Ontario, M5G 2C4

Other trials in Canada

South Korea4 sites

  • Anam Hospital | Endocrinology and Metabolism

    Seongbuk, Seoul, 02841

  • Seoul National University Hospital | Endocrinology and Metabolism

    Seoul, Seoul, 03080

  • Severance Hospital | Endocrinology and Metabolism

    Seoul, Seoul, 03722

  • Asan Medical Center | Endocrinology and Metabolism

    Seoul, Seoul, 05505

Other trials in South Korea

Germany2 sites

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

    Bad Oeynhausen, North Rhine-Westphalia, 32545

  • InnoDiab Forschung GmbH

    Essen, North Rhine-Westphalia, 45136

Other trials in Germany

About this study

Official title: 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

Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 1 diabetes.

In people with type 1 diabetes, the body does not make enough of a hormone called insulin, resulting in high blood sugar levels that can cause damage to the kidneys. CKD often occurs together with or as a consequence of type 1 diabetes.

Read more

The study treatment finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is approved for doctors to prescribe to people with CKD and type 2 diabetes.

In this study, researchers want to learn if finerenone works better than placebo in reducing the participants' kidney disease from getting worse when given in addition to standard of care (SOC) treatment. A placebo looks like a treatment but does not have any medicine in it. SOC is a procedure or treatment that medical experts consider most appropriate for a condition or disease. To find out how well finerenone works, the level of a protein (albumin) in the urine will be measured.

Researchers also want to know how safe finerenone is. To do this, the researchers will collect the number of participants with:

  • medical problems (also called treatment-emergent adverse events (TEAEs))
  • serious TEAEs. A TEAE is considered 'serious' when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important
  • higher than normal blood levels of potassium (hyperkalaemia). Depending on the treatment group, the participants will either take finerenone or placebo, Importantly, the participants will also continue to take their regular SOC medicines.

The participants will be in the study for up to 7.5 months and will take the study treatments for 6 months. During the study, they will visit the study site at least 6 times.

The study team will:

  • collect blood and urine samples
  • check the participants' vital signs such as blood pressure and heart rate
  • do a physical examination including height and weight
  • check the participants' heart health by using an electrocardiogram (ECG)
  • do pregnancy tests in women of childbearing potential
Being tested
Finerenone, Placebo
Medical subject headings
Renal Insufficiency, Chronic, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FinerenoneDrug

    Dose A, Dose B, oral

  • PlaceboOther

    Oral

Study groups in NCT05901831
Study groupRoleWhat they receive
Finerenone armExperimentalParticipants with eGFR ≥25 to <60 mL/min/1.73 m^2 at Screening visit will take Finerenone Dose A. Participants with eGFR ≥60 mL/min/1.73 m^2 at Screening visit will take Dose B. Up-titration and down-titration of study intervention will be based on local potassium and kidney function (eGFR) values. Treatment duration is 6 months.
Receives: Drug: Finerenone
Placebo armPlacebo comparatorParticipants will take Finerenone matching placebo for 6 months.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in UACR From Baseline (Ratio to Baseline) Over 6 Months

    UACR was assessed by a central laboratory at baseline, Month 3, and Month 6. The primary efficacy variable was change in UACR from baseline over 6 months, which was evaluated on the average of the Month 3 and Month 6 geometric mean UACR ratios to baseline within each treatment arm. A ratio to baseline below 1 indicates a reduction in UACR, with a smaller value indicating a better outcome. Both values were used to assess the treatment effect, with a ratio finerenone-versus-placebo below 1 indicating a better outcome with finerenone relative to placebo.

    Measured: From baseline to Month 6

Secondary outcomes (2)

  1. Number of Participants With Treatment-emergent AEs (TEAEs), Treatment-emergent SAEs (TESAEs)

    AE: An adverse event (AE) in this study is defined as any medical problem that the participants had during the study. This includes any new medical issue or a worsening of an existing condition that happens after the participant receives the study treatment, regardless of whether it is considered related to the study treatment. AEs that started or worsened after the first dose of study intervention up to 3 days after any temporary or permanent interruption of study intervention were considered as TEAEs; for the targeted AE reporting, non-serious AEs were not mandatory to be collected.

    Measured: From the first dose of study intervention and up to 3 days after the last dose of study intervention, with a median treatment duration 6.07 months.

  2. Number of Participants With Treatment-emergent Hyperkalaemia

    Hyperkalemia (evaluated as the combined MedDRA Preferred terms blood potassium increased and hyperkalaemia) was an adverse event of special interest in this study and collected in the electronic case report form (eCRF).

    Measured: From the first dose of study intervention and up to 3 days after the last dose of study intervention, with a median treatment duration 6.07 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2023
  2. Study start26 Feb 2024
  3. Primary completion20 Aug 2025
  4. Study completion15 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05901831
Sponsor's protocol ID
22267
Other IDs
2022-503024-27-00
Acronym
FINE-ONE
Status last verified
1 Aug 2026
First submitted
5 Jun 2023
Last updated
27 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Publications

  • Heerspink HJL, Birkenfeld AL, Cherney DZI, Colhoun HM, Groop PH, Ji L, Jongs N, Mathieu C, Pratley RE, Rosas SE, Rossing P, Skyler JS, Tuttle KR, Lawatscheck R, Brinker M, Scheerer MF, Russell J, Schloemer P, McGill JB; FINE-ONE Investigators. Finerenone in Type 1 Diabetes and Chronic Kidney Disease. N Engl J Med. 2026 Mar 5;394(10):947-957. doi: 10.1056/NEJMoa2512854.

    PubMed 41780000

  • Kugathasan L, Aronson Y, Sridhar VS, Ni H, Ouimet JP, Limonte CP, Sarma S, Cherney DZI. Advancing kidney protection in type 1 diabetes: insights from emerging therapies in type 2 diabetes and chronic kidney disease. Expert Rev Clin Immunol. 2025 Aug;21(8):1113-1134. doi: 10.1080/1744666X.2025.2537446. Epub 2025 Jul 24.

    PubMed 40693871

  • Heerspink HJL, Birkenfeld AL, Cherney DZI, Colhoun HM, Ji L, Mathieu C, Groop PH, Pratley RE, Rosas SE, Rossing P, Skyler JS, Tuttle KR, Lawatscheck R, Scott C, Edfors R, Scheerer MF, Kolkhof P, McGill JB. Rationale and design of a randomised phase III registration trial investigating finerenone in participants with type 1 diabetes and chronic kidney disease: The FINE-ONE trial. Diabetes Res Clin Pract. 2023 Oct;204:110908. doi: 10.1016/j.diabres.2023.110908. Epub 2023 Oct 5.

    PubMed 37805000

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Finerenone in people with Chronic Kidney Disease and Type 1 Diabetes Mellitus, run by Bayer at 79 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United States, China, Italy, United Kingdom, Denmark and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in UACR From Baseline (Ratio to Baseline) Over 6 Months (time frame: From baseline to Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05901831, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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