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
- Conditions
- Chronic Kidney DiseaseType 1 Diabetes Mellitus
- Interventions
- Other: Placebo
- Registration Number
- NCT05901831
- Lead Sponsor
- Bayer
- Brief 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 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 220
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Finerenone arm Finerenone 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. Placebo arm Placebo Participants will take Finerenone matching placebo for 6 months.
- Primary Outcome Measures
Name Time Method Change in Urinary albumin-to-creatinine ratio (UACR) From baseline up to 6 months UACR will be assessed by the Central laboratory.
- Secondary Outcome Measures
Name Time Method Number of participants with Hyperkalaemia From baseline up to 7 months Hyperkalemia will be an adverse events of special interest (AESI).
Number of participants with treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse event (TESAEs) From baseline up to 7 months
Trial Locations
- Locations (81)
Hospital Gregorio Maranon | Endocrinology Department
🇪🇸Madrid, Spain
Elixia Central Florida
🇺🇸Orlando, Florida, United States
The Central Hospital of Wuhan, Tongji Medl Collg Huazhong...
🇨🇳Wuhan, Hubei, China
AdventHealth Translational Research Institute
🇺🇸Orlando, Florida, United States
Physicians East, P.A.- W. H. Smith - Endocrinology
🇺🇸Greenville, North Carolina, United States
OHSU Physicians Pavillion - Endocrinology
🇺🇸Portland, Oregon, United States
Southwest Kidney Institute, PLC
🇺🇸Surprise, Arizona, United States
Stanford University | Endocrinology Department - Diabetes Research
🇺🇸Stanford, California, United States
Touro University (TU) - College of Osteopathic Medicine (TUCOM) - California
🇺🇸Vallejo, California, United States
University of Miami Leonard M. Miller School of Medicine (UMMSM) - Peggy and Harold Katz Family Drug Discovery Center
🇺🇸Miami, Florida, United States
Hanson Clinical Research Center, Inc.
🇺🇸Port Charlotte, Florida, United States
Jedidiah Clinical Research
🇺🇸Tampa, Florida, United States
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
Grady Memorial Hospital - Endocrinology
🇺🇸Atlanta, Georgia, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
Northwestern University | Feinberg School of Medicine - Division of Endocrinology, Metabolism and Molecular Medicine
🇺🇸Chicago, Illinois, United States
The University of Chicago Medicine Kovler Diabetes Center
🇺🇸Chicago, Illinois, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
Wichita Nephrology Group Pa
🇺🇸Wichita, Kansas, United States
Omega Clinical Research Center
🇺🇸Metairie, Louisiana, United States
MedStar Health Research Institute
🇺🇸Hyattsville, Maryland, United States
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States
University of Missouri Health Care
🇺🇸Columbia, Missouri, United States
Washington University School of Medicine in St. Louis
🇺🇸Saint Louis, Missouri, United States
University of North Carolina (UNC) - Hospitals Outpatient Center at Eastowne
🇺🇸Chapel Hill, North Carolina, United States
Accellacare - Wilmington
🇺🇸Wilmington, North Carolina, United States
Cleveland Clinic - Main Campus
🇺🇸Cleveland, Ohio, United States
University of Texas Health San Antonio
🇺🇸San Antonio, Texas, United States
Consano Clinical Research, LLC.
🇺🇸San Antonio, Texas, United States
EVMS Strelitz Diabetes Center
🇺🇸Norfolk, Virginia, United States
Providence Medical Group - Spokane Nephrology - Providence Kidney Care Spokane
🇺🇸Spokane, Washington, United States
Richmond Road Diagnostic and Treatment Centre - Clinical Trials Unit(RRDTC)
🇨🇦Calgary, Alberta, Canada
Alberta Diabetes Institute - Clinical Research Unit (CRU)
🇨🇦Edmonton, Alberta, Canada
Toronto General Hospital - University Health Network, Renal Physiology laboratory
🇨🇦Toronto, Ontario, Canada
Centre de Recherche Clinique de Laval
🇨🇦Laval, Quebec, Canada
McGill University Health Centre (MUHC) - Research Institute (RI) - McConnell Centre for Innovative Medicine (CIM)
🇨🇦Montreal, Quebec, Canada
Zhongshan People's Hospital
🇨🇳Zhongshan, Guangdong, China
The 4th Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Affiliated Hospital of Jiangsu University
🇨🇳JiangSu, Jiangsu, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shanxi, China
Peking University People's Hospital
🇨🇳Beijing, China
Southern Medical University - Nanfang Hospital (Southern Hospital)
🇨🇳Guangzhou, China
Nanjing Medical University (NMU) - Huai'an First People's Hospital
🇨🇳Huai An, China
Nanjing Medical University (NMU) - The Second Affiliated Hospital
🇨🇳Nanjing, China
Shanghai Jiao Tong University (SJTU) - Shanghai General Hospital (Shanghai First People's Hospital) - Northern Location
🇨🇳Shanghai, China
Central Hospital of Minhang District, Shanghai
🇨🇳Shanghai, China
Zhongshan Hospital Fudan University, Qingpu Branch
🇨🇳Shanghai, China
Hospital of South West Jutland | Department of Endocrinology Research
🇩🇰Esbjerg, Denmark
Region Nordjylland | Aalborg University Hospital - Endocrinology Department
🇩🇰Gistrup, Denmark
Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department
🇩🇰Herlev, Denmark
Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department
🇩🇰Herning, Denmark
Capital Region | Nordsjaellands Hospital - Hillerod - Endocrinology Ambulatory Research Unit
🇩🇰Hillerod, Denmark
Odense University Hospital | Odense - Endocrinology Department
🇩🇰Odense, Denmark
InnoDiab Forschung GmbH
🇩🇪Essen, Nordrhein-Westfalen, Germany
Ruhr-Universitaet Bochum - Herz und Diabeteszentrum NRW (Heart and Diabetes Center)
🇩🇪Bad Oeynhausen, Germany
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Endocrinologia e prevenzione e cura del diabete
🇮🇹Bologna, Emilia-Romagna, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Diabetologia
🇮🇹Roma, Lazio, Italy
Careggi University Hospital - Diabetologia e Malattie del Metabolismo
🇮🇹Firenze, Toscana, Italy
ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia
🇮🇹Bergamo, Italy
Azienda Sanitaria Locale di Chieri | TO5 - SC Diabetologia Territoriale
🇮🇹Chieri, Italy
Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia
🇮🇹Chieti, Italy
ASST Fatebenefratelli Sacco _Ospedale Sacco - Malattie Endocrine e Diabetologia
🇮🇹Milano, Italy
IRCCS Ospedale San Raffaele | Diabetologia Department - Cardio-Metabolic and Clinica Trials Unit
🇮🇹Milan, Italy
ASST Santi Paolo e Carlo | San Paolo Hospital - Haemostasis and Thrombosis Department
🇮🇹Milan, Italy
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition
🇪🇸A Coruna, A Coruña, Spain
Hospital Vithas Sevilla | Endocrinology Department
🇪🇸Castilleja de la Cuesta, Sevilla, Spain
Hospital Clinic de Barcelona | Instituto Clinic de Enfermedades Digestivas y Metabolicas - Endocrinologia y Nutricion
🇪🇸Barcelona, Spain
Hospital Universitario Puerta de Hierro Majadahonda | Clinical Pharmacology Department
🇪🇸Majadahonda, Spain
Hospital Universitario Virgen de la Victoria | Unidad de Investigacion Clinica - Endocrinology Department
🇪🇸Malaga, Spain
North Bristol NHS Trust - Southmead Hospital
🇬🇧Bristol, United Kingdom
Cardiff and Vale University Health Board - University Hospital of Wales (UHW)
🇬🇧Cardiff, United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
🇬🇧Derby, United Kingdom
NHS Greater Glasgow and Clyde (NHSGGC) - Glasgow Royal Infirmary (GRI)
🇬🇧Glasgow, United Kingdom
Royal London Hospital
🇬🇧London, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
Walsall Healthcare NHS Trust - Manor Hospital
🇬🇧Walsall, United Kingdom