Clinical trial NCT05901831: 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Chronic Kidney Disease
Type 1 Diabetes Mellitus
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2023-06-13
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Urinary albumin-to-creatinine ratio (UACR)
timeFrame: From baseline up to 6 months
Secondary outcomes:
measure: Number of participants with treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse event (TESAEs)
timeFrame: From baseline up to 7 months
measure: Number of participants with Hyperkalaemia
timeFrame: From baseline up to 7 months
Other outcomes:
Locations:
city: Surprise
country: United States
facility: Southwest Kidney Institute, PLC - Suprise
state: Arizona
city: Stanford
country: United States
facility: Stanford Endocrinology Clinic
state: California
city: Vallejo
country: United States
facility: Touro University (TU) - College of Osteopathic Medicine (TUCOM) - California
state: California
city: Miami
country: United States
facility: University of Miami Leonard M. Miller School of Medicine (UMMSM) - Peggy and Harold Katz Family Drug Discovery Center
state: Florida
city: Orlando
country: United States
facility: AdventHealth Translational Research Institute
state: Florida
city: Orlando
country: United States
facility: Elixia Central Florida
state: Florida
city: Port Charlotte
country: United States
facility: Hanson Clinical Research Center, Inc.
state: Florida
city: Tampa
country: United States
facility: Jedidiah Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Atlanta
country: United States
facility: Grady Memorial Hospital - Endocrinology
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Chicago
country: United States
facility: Northwestern University | Feinberg School of Medicine - Division of Endocrinology, Metabolism and Molecular Medicine
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medicine Kovler Diabetes Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Wichita
country: United States
facility: Wichita Nephrology Group Pa
state: Kansas
city: Metairie
country: United States
facility: Diabetes & Metabolism Associates
state: Louisiana
city: Hyattsville
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: Chapel Hill
country: United States
facility: University of North Carolina (UNC) - Hospitals Outpatient Center at Eastowne
state: North Carolina
city: Greenville
country: United States
facility: Physicians East, P.A.- W. H. Smith - Endocrinology
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare - Wilmington
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic - Main Campus
state: Ohio
city: Portland
country: United States
facility: OHSU Physicians Pavillion - Endocrinology
state: Oregon
city: San Antonio
country: United States
facility: University of Texas Health San Antonio
state: Texas
city: San Antonio
country: United States
facility: Consano Clinical Research, LLC.
state: Texas
city: Norfolk
country: United States
facility: EVMS Strelitz Diabetes Center
state: Virginia
city: Spokane Valley
country: United States
facility: Providence Medical Research Center
state: Washington
city: Calgary
country: Canada
facility: Richmond Road Diagnostic and Treatment Centre - Clinical Trials Unit(RRDTC)
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Diabetes Institute - Clinical Research Unit (CRU)
state: Alberta
city: Toronto
country: Canada
facility: Toronto General Hospital - University Health Network, Renal Physiology laboratory
state: Ontario
city: Laval
country: Canada
facility: Centre de Recherche Clinique de Laval
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC) - Research Institute (RI) - McConnell Centre for Innovative Medicine (CIM)
state: Quebec
city: Zhongshan
country: China
facility: Zhongshan People's Hospital
state: Guangdong
city: Harbin
country: China
facility: The 4th Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: The Central Hospital of Wuhan, Tongji Medl Collg Huazhong...
state: Hubei
city: JiangSu
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Beijing
country: China
facility: Peking University People's Hospital
city: Guangzhou
country: China
facility: Southern Medical University - Nanfang Hospital (Southern Hospital)
city: Huai An
country: China
facility: Nanjing Medical University (NMU) - Huai'an First People's Hospital
city: Nanjing
country: China
facility: Nanjing Medical University (NMU) - The Second Affiliated Hospital
city: Shanghai
country: China
facility: Shanghai Jiao Tong University (SJTU) - Shanghai General Hospital (Shanghai First People's Hospital) - Northern Location
city: Shanghai
country: China
facility: Central Hospital of Minhang District, Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University, Qingpu Branch
city: Esbjerg
country: Denmark
facility: Hospital of South West Jutland | Department of Endocrinology Research
city: Gistrup
country: Denmark
facility: Region Nordjylland | Aalborg University Hospital - Endocrinology Department
city: Herlev
country: Denmark
facility: Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department
city: Herning
country: Denmark
facility: Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department
city: Hillerod
country: Denmark
facility: Capital Region | Nordsjaellands Hospital - Hillerod - Endocrinology Ambulatory Research Unit
city: Odense
country: Denmark
facility: Odense University Hospital | Odense - Endocrinology Department
city: Essen
country: Germany
facility: InnoDiab Forschung GmbH
state: Nordrhein-Westfalen
city: Bad Oeynhausen
country: Germany
facility: Ruhr-Universitaet Bochum - Herz und Diabeteszentrum NRW (Heart and Diabetes Center)
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Endocrinologia e prevenzione e cura del diabete
state: Emilia-Romagna
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Diabetologia
state: Lazio
city: Firenze
country: Italy
facility: Careggi University Hospital - Diabetologia e Malattie del Metabolismo
state: Toscana
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia
city: Chieri
country: Italy
facility: Azienda Sanitaria Locale di Chieri | TO5 - SC Diabetologia Territoriale
city: Chieti
country: Italy
facility: Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco _Ospedale Sacco - Malattie Endocrine e Diabetologia
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele | Diabetologia Department - Cardio-Metabolic and Clinica Trials Unit
city: Milan
country: Italy
facility: ASST Santi Paolo e Carlo | San Paolo Hospital - Haemostasis and Thrombosis Department
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: A Coruna
country: Spain
facility: Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition
state: A Coruña
city: Castilleja de la Cuesta
country: Spain
facility: Hospital Nisa Sevilla Aljarafe - Endocrinologia
state: Sevilla
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona | Instituto Clinic de Enfermedades Digestivas y Metabolicas - Endocrinologia y Nutricion
city: Madrid
country: Spain
facility: Hospital Gregorio Maranon | Endocrinology Department
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta De Hierro De Majadahonda - Endocrinologia
city: Malaga
country: Spain
facility: Hospital Universitario Virgen De La Victoria - Endocrinologia
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust - Southmead Hospital
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant
city: Derby
country: United Kingdom
facility: University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde (NHSGGC) - Glasgow Royal Infirmary (GRI)
city: London
country: United Kingdom
facility: Barts Health NHS Trust - Royal London Hospital - Nephrology
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Walsall
country: United Kingdom
facility: Walsall Healthcare NHS Trust - Manor Hospital
Study officials:
References: