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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified September 2025 by Bayer
Sponsor
Bayer
Information Provided by (Responsible Party)
Bayer
Clinicaltrials.gov Identifier
NCT05901831
Other Study ID Numbers:
22267
First Submitted
June 4, 2023
First Posted
June 12, 2023
Last Update Posted
October 20, 2025
Last Verified
September 2025

ClinicalTrials.gov processed this data on October 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Chronic Kidney DiseaseType 1 Diabetes Mellitus
Drug: FinerenoneOther: Placebo

Study Design

Study TypeInterventional
Actual Enrollment241 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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
Study Start DateFebruary 25, 2024
Actual Primary Completion DateAugust 19, 2025
Actual Study Completion DateSeptember 14, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
Finerenone arm
Participants 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.
Drug: Finerenone
Dose A, Dose B, oral
Placebo arm
Participants will take Finerenone matching placebo for 6 months.
Other: Placebo
Oral

Outcome Measures

Primary Outcome Measures
  1. Change in Urinary albumin-to-creatinine ratio (UACR)
    UACR will be assessed by the Central laboratory.
Secondary Outcome Measures
  1. Number of participants with treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse event (TESAEs)
  2. Number of participants with Hyperkalaemia
    Hyperkalemia will be an adverse events of special interest (AESI).

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsBayer
Locations
Southwest Kidney Institute, PLC - Suprise | Surprise Arizona, United States, 85374Stanford Endocrinology Clinic | Stanford California, United States, 94305Touro University California - Metabolic Research Center | Vallejo California, United States, 94592UHealth Diabetes Research Center | Miami Florida, United States, 33136AdventHealth Translational Research Institute | Orlando Florida, United States, 32804Elixia Central Florida | Orlando Florida, United States, 32806Hanson Clinical Research Center, Inc. | Port Charlotte Florida, United States, 33952Jedidiah Clinical Research | Tampa Florida, United States, 33619Metabolic Research Institute, Inc. | West Palm Beach Florida, United States, 33401Grady Memorial Hospital - Endocrinology | Atlanta Georgia, United States, 30303Northwestern University | Feinberg School of Medicine - Division of Endocrinology, Metabolism and Molecular Medicine | Chicago Illinois, United States, 60611UChicago Medicine Kovler Diabetes Center | Chicago Illinois, United States, 60637Preventive Intervention Center - Endocrinology | Iowa City Iowa, United States, 52202Wichita Nephrology Group Pa | Wichita Kansas, United States, 67214Diabetes & Metabolism Associates | Metairie Louisiana, United States, 70006MedStar Health Research Institute | Hyattsville Maryland, United States, 20782Joslin Diabetes Center | Boston Massachusetts, United States, 02215MU Health Care - University Hospital - Endocrinology | Columbia Missouri, United States, 65212Washington University School of Medicine in St. Louis | St Louis Missouri, United States, 63110-1010UNC Endocrinology, Diabetes, and Obesity Clinical Research Unit | Chapel Hill North Carolina, United States, 27514Physicians East, P.A.- W. H. Smith - Endocrinology | Greenville North Carolina, United States, 27834Accellacare - Wilmington | Wilmington North Carolina, United States, 28401Cleveland Clinic - Main Campus | Cleveland Ohio, United States, 44195OHSU Physicians Pavillion - Endocrinology | Portland Oregon, United States, 97239UT Health San Antonio - Medical Arts & Research Center - Endocrinology | San Antonio Texas, United States, 78229Consano Clinical Research, LLC. | San Antonio Texas, United States, 79231EVMS Strelitz Diabetes Center | Norfolk Virginia, United States, 23510Providence Medical Research Center | Spokane Valley Washington, United States, 99204Richmond Road Diagnostic and Treatment Centre - Clinical Trials Unit(RRDTC) | Calgary Alberta, Canada, T2T 5C7Alberta Diabetes Institute - Clinical Research Unit (CRU) | Edmonton Alberta, Canada, T6G 2E1Toronto General Hospital - University Health Network, Renal Physiology laboratory | Toronto Ontario, Canada, M5G 2C4Centre de Recherche Clinique de Laval | Laval Quebec, Canada, H7T 2P5McGill University Health Centre (MUHC) - Research Institute (RI) - McConnell Centre for Innovative Medicine (CIM) | Montreal Quebec, Canada, H4A 3J1Zhongshan People's Hospital | Zhongshan Guangdong, China, 528499The 4th Affiliated Hospital of Harbin Medical University | Harbin Heilongjiang, China, 150001The Central Hospital of Wuhan, Tongji Medl Collg Huazhong... | Wuhan Hubei, China, 430014Affiliated Hospital of Jiangsu University | JiangSu Jiangsu, China, 212001Shanxi Bethune Hospital | Taiyuan Shanxi, China, 030032Peking University People's Hospital | Beijing , China, 100032Southern Medical University - Nanfang Hospital (Southern Hospital) | Guangzhou , China, 510515Huai'an First People's Hospital, Nanjing Medical University | Huai'an , China, 223300Nanjing Medical University (NMU) - The Second Affiliated Hospital | Nanjing , China, 210011Shanghai Jiao Tong University (SJTU) - Shanghai General Hospital (Shanghai First People's Hospital) - Northern Location | Shanghai , China, 200080Central Hospital of Minhang District, Shanghai | Shanghai , China, 201100Zhongshan Hospital Fudan University, Qingpu Branch | Shanghai , China, 201700Hospital of South West Jutland | Department of Endocrinology Research | Esbjerg , Denmark, 6700Region Nordjylland | Steno Diabetes Center Nordjylland - Endocrinology Department | Gistrup , Denmark, 9260Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department | Herlev , Denmark, 2730Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department | Herning , Denmark, DK-7400Capital Region | Nordsjaellands Hospital - Hillerod - Endocrinology Ambulatory Research Unit | Hillerød , Denmark, 3400Odense University Hospital | Odense - Endocrinology Department | Odense , Denmark, 5000InnoDiab Forschung GmbH | Essen North Rhine-Westphalia, Germany, 45136Ruhr-Universitaet Bochum - Herz und Diabeteszentrum NRW (Heart and Diabetes Center) | Bad Oeynhausen , Germany, 32545Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Endocrinologia e prevenzione e cura del diabete | Bologna Emilia-Romagna, Italy, 40138Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Diabetologia | Rome Lazio, Italy, 00168Careggi University Hospital - Diabetologia e Malattie del Metabolismo | Florence Tuscany, Italy, 50134ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia | Bergamo , Italy, 24127Azienda Sanitaria Locale di Chieri | TO5 - SC Diabetologia Territoriale | Chieri , Italy, 10023Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia | Chieti , Italy, 66100IRCCS Ospedale San Raffaele | Diabetologia Department - Cardio-Metabolic and Clinica Trials Unit | Milan , Italy, 20132ASST Santi Paolo e Carlo | San Paolo Hospital - Haemostasis and Thrombosis Department | Milan , Italy, 20142ASST Fatebenefratelli Sacco _Ospedale Sacco - Malattie Endocrine e Diabetologia | Milan , Italy, 20157Severance Hospital, Yonsei University Health System | Seoul Seoul Teugbyeolsi, South Korea, 03722Asan Medical Center - Oncology Department | Seoul Seoul Teugbyeolsi, South Korea, 05505Seoul National University Hospital | Seoul Seoul Teugbyeolsi, South Korea, 3080Korea University Anam Hospital | Seoul , South Korea, 02841Samsung Medical Center | Seoul , South Korea, 06351Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition | A Coruña A Coruña, Spain, 15006Hospital Nisa Sevilla Aljarafe - Endocrinologia | Castilleja de la Cuesta Sevilla, Spain, 41950Hospital Clinic de Barcelona | Instituto Clinic de Enfermedades Digestivas y Metabolicas - Endocrinologia y Nutricion | Barcelona , Spain, 08036Hospital Gregorio Maranon | Endocrinology Department | Madrid , Spain, 28007Hospital Universitario Puerta De Hierro De Majadahonda - Endocrinologia | Majadahonda , Spain, 28222Hospital Universitario Virgen De La Victoria - Endocrinologia | Málaga , Spain, 29010North Bristol NHS Trust | Southmead Hospital - Clinical Research Centre | Bristol , United Kingdom, BS10 5NBCardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant | Cardiff , United Kingdom, CF14 4XWUniversity Hospitals of Derby and Burton NHS Foundation Trust | Royal Derby Hospital - Renal Research | Derby , United Kingdom, DE22 3NENHS Greater Glasgow and Clyde (NHSGGC) - Glasgow Royal Infirmary (GRI) | Glasgow , United Kingdom, G4 0SFBarts Health NHS Trust - Royal London Hospital - Nephrology | London , United Kingdom, E1 1BBManchester University NHS Foundation Trust | Wythenshawe Hospital - Clinical Research Facility | Manchester , United Kingdom, M23 9LTWalsall Healthcare NHS Trust | Manor Hospital - Nephrology | Walsall , United Kingdom, WS2 9PS