do_not_disturb_altRecruitment Complete

Chronic kidney disease, Type 1 diabetes mellitus

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

Trial purpose

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.
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. An 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

Key Participants Requirements

Sex

All

Age

18 - N/A

Trial summary

Enrollment Goal
220
Trial Dates
February 2024 - September 2025
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Region Midtjylland | Regionshospitalet Godstrup - Nephrology DepartmentHerning, DK-7400, Denmark
Completed
Grady Memorial Hospital - EndocrinologyAtlanta, 30303, United States
Completed
Stanford Endocrinology ClinicStanford, 94305, United States
Withdrawn
Carolina Health Specialists - Medical Complex - 82nd ParkwayMyrtle Beach, 29572, United States
Completed
EVMS Strelitz Diabetes CenterNorfolk, 23510, United States
Completed
Hospital of South West Jutland | Department of Endocrinology ResearchEsbjerg, 6700, Denmark
Active, not recruiting
ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-DiabetologiaBergamo, 24127, Italy
Completed
Azienda Sanitaria Locale di Chieri | TO5 - SC Diabetologia TerritorialeChieri, 10023, Italy
Active, not recruiting
ASST Fatebenefratelli Sacco _Ospedale Sacco - Malattie Endocrine e DiabetologiaMilano, 20157, Italy
Completed
UNC Endocrinology, Diabetes, and Obesity Clinical Research UnitChapel Hill, 27514, United States
Active, not recruiting
Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research DepartmentHerlev, 2730, Denmark
Active, not recruiting
Odense University Hospital | Odense - Endocrinology DepartmentOdense, 5000, Denmark
Completed
Region Nordjylland | Steno Diabetes Center Nordjylland - Endocrinology DepartmentGistrup, 9260, Denmark
Completed
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Endocrinologia e prevenzione e cura del diabeteBologna, 40138, Italy
Completed
ASST Santi Paolo e Carlo | San Paolo Hospital - Haemostasis and Thrombosis DepartmentMilan, 20142, Italy
Active, not recruiting
IRCCS Ospedale San Raffaele | Diabetologia Department - Cardio-Metabolic and Clinica Trials UnitMilan, 20132, Italy
Active, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD DiabetologiaRoma, 00168, Italy
Active, not recruiting
Università degli Studi "G. D'Annunzio" di Chieti - EndocrinologiaChieti, 66100, Italy
Completed
Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and NutritionA Coruna, 15006, Spain
Completed
Jedidiah Clinical ResearchTampa, 33619, United States
Completed
Washington University School of Medicine in St. LouisSaint Louis, 63110-1010, United States
Withdrawn
Barbara Davis Center for Diabetes - Anschutz Medical Campus - Pediatric ClinicAurora, 80045, United States
Completed
Elixia Central FloridaOrlando, 32806, United States
Completed
Hospital Gregorio Maranon | Endocrinology DepartmentMadrid, 28007, Spain
Completed
Hospital Universitario Virgen De La Victoria - EndocrinologiaMalaga, 29010, Spain
Completed
Hospital Universitario Puerta De Hierro De Majadahonda - EndocrinologiaMajadahonda, 28222, Spain
Completed
Hospital Clinic de Barcelona | Instituto Clinic de Enfermedades Digestivas y Metabolicas - Endocrinologia y NutricionBarcelona, 08036, Spain
Completed
Hospital Nisa Sevilla Aljarafe - EndocrinologiaCastilleja de la Cuesta, 41950, Spain
Completed
Capital Region | Nordsjaellands Hospital - Hillerod - Endocrinology Ambulatory Research UnitHillerod, 3400, Denmark
Completed
Cleveland Clinic - Main CampusCleveland, 44195, United States
Active, not recruiting
Northwestern University | Feinberg School of Medicine - Division of Endocrinology, Metabolism and Molecular MedicineChicago, 60611, United States
Completed
MedStar Health Research InstituteHyattsville, 20782, United States
Completed
Barts Health NHS Trust - Royal London Hospital - NephrologyLondon, E1 1BB, United Kingdom
Completed
Ruhr-Universitaet Bochum - Herz und Diabeteszentrum NRW (Heart and Diabetes Center)Bad Oeynhausen, 32545, Germany
Completed
InnoDiab Forschung GmbHEssen, 45136, Germany
Completed
Korea University Anam Hospitalseoul, 02841, Korea,_republic_of
Completed
Seoul National University HospitalSeoul, 3080, Korea,_republic_of
Completed
Asan Medical Center - Oncology DepartmentSeoul, 05505, Korea,_republic_of
Completed
Hanson Clinical Research Center, Inc.Port Charlotte, 33952, United States
Completed
Preventive Intervention Center - EndocrinologyIowa City, 52202, United States
Active, not recruiting
Diabetes & Metabolism AssociatesMetairie, 70006, United States
Completed
Careggi University Hospital - Diabetologia e Malattie del MetabolismoFirenze, 50134, Italy
Completed
Physicians East, P.A.- W. H. Smith - EndocrinologyGreenville, 27834, United States
Completed
MU Health Care - University Hospital - EndocrinologyColumbia, 65212, United States
Completed
Touro University California - Metabolic Research CenterVallejo, 94592, United States
Active, not recruiting
Metabolic Research Institute, Inc.West Palm Beach, 33401, United States
Withdrawn
Tulane Medical Center (TMC) - Tulane Lakeside Specialty ClinicMetairie, 70001-1210, United States
Withdrawn
Christiana Care Health System (Services)Newark, 19718, United States
Completed
UHealth Diabetes Research CenterMiami, 33136, United States
Completed
Richmond Road Diagnostic and Treatment Centre - Clinical Trials Unit(RRDTC)Calgary, T2T 5C7, Canada
Completed
Centre de Recherche Clinique de LavalLaval, H7T 2P5, Canada
Active, not recruiting
Toronto General Hospital - University Health Network, Renal Physiology laboratoryToronto, M5G 2C4, Canada
Completed
Southern Medical University - Nanfang Hospital (Southern Hospital)Guangzhou, 510515, China
Completed
Joslin Diabetes CenterBoston, 02215, United States
Withdrawn
Metabolism Endocrinology & Diabetes Clinic at Domino's FarmsAnn Arbor, 48105, United States
Completed
Central Hospital of Minhang District, ShanghaiShanghai, 201100, China
Completed
Huai'an First People's Hospital, Nanjing Medical UniversityHuai An, 223300, China
Completed
Nanjing Medical University (NMU) - The Second Affiliated HospitalNanjing, 210011, China
Completed
Zhongshan People's HospitalZhongshan, 528499, China
Completed
NHS Greater Glasgow and Clyde (NHSGGC) - Glasgow Royal Infirmary (GRI)Glasgow, G4 0SF, United Kingdom
Active, not recruiting
Manchester University NHS Foundation Trust | Wythenshawe Hospital - Clinical Research FacilityManchester, M23 9LT, United Kingdom
Completed
North Bristol NHS Trust - Southmead HospitalBristol, BS10 5NB, United Kingdom
Active, not recruiting
Walsall Healthcare NHS Trust - Manor HospitalWalsall, WS2 9PS, United Kingdom
Completed
University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby HospitalDerby, DE22 3NE, United Kingdom
Completed
Alberta Diabetes Institute - Clinical Research Unit (CRU)Edmonton, T6G 2E1, Canada
Completed
The 4th Affiliated Hospital of Harbin Medical UniversityHarbin, 150001, China
Completed
Shanxi Bethune HospitalTaiyuan, 030032, China
Completed
Peking University People's HospitalBeijing, 100032, China
Active, not recruiting
McGill University Health Centre (MUHC) - Research Institute (RI) - McConnell Centre for Innovative Medicine (CIM)Montreal, H4A 3J1, Canada
Completed
Wichita Nephrology Group PaWichita, 67214, United States
Completed
Severance Hospital, Yonsei University Health SystemSeoul, 03722, Korea,_republic_of
Completed
Zhongshan Hospital Fudan University, Qingpu Branchshanghai, 201700, China
Completed
The Central Hospital of Wuhan, Tongji Medl Collg Huazhong...Wuhan, 430014, China
Completed
Affiliated Hospital of Jiangsu UniversityJiangSu, 212001, China
Active, not recruiting
Consano Clinical Research, LLC.San Antonio, 79231, United States
Active, not recruiting
UT Health San Antonio - Medical Arts & Research Center - EndocrinologySan Antonio, 78229, United States
Completed
Providence Medical Research CenterSpokane Valley, 99204, United States
Active, not recruiting
AdventHealth Translational Research InstituteOrlando, 32804, United States
Completed
Shanghai Jiao Tong University (SJTU) - Shanghai General Hospital (Shanghai First People's Hospital) - Northern LocationShanghai, 200080, China
Completed
OHSU Physicians Pavillion - EndocrinologyPortland, 97239, United States
Active, not recruiting
UChicago Medicine Kovler Diabetes CenterChicago, 60637, United States
Withdrawn
Atlanta Diabetes AssociatesAtlanta, 30318, United States
Completed
Accellacare - WilmingtonWilmington, 28401, United States
Not yet recruiting
Samsung Medical CenterSeoul, 06351, Korea,_republic_of
Active, not recruiting
Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and TransplantCardiff, CF14 4XW, United Kingdom
Completed
Southwest Kidney Institute, PLC - SupriseSurprise, 85374, United States
Withdrawn
National Institute of Clinical Research - Garden GroveGarden Grove, 92844, United States

Primary Outcome

  • Change in Urinary albumin-to-creatinine ratio (UACR)
    UACR will be assessed by the Central laboratory.
    date_rangeTime Frame:
    From baseline up to 6 months

Secondary Outcome

  • Number of participants with treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse event (TESAEs)
    date_rangeTime Frame:
    From baseline up to 7 months
  • Number of participants with Hyperkalaemia
    Hyperkalemia will be an adverse events of special interest (AESI).
    date_rangeTime Frame:
    From baseline up to 7 months

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2