FINE-ONE: 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
Study Details
Study Description
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:
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medical problems (also called treatment-emergent adverse events (TEAEs))
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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
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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:
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collect blood and urine samples
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check the participants' vital signs such as blood pressure and heart rate
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do a physical examination including height and weight
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check the participants' heart health by using an electrocardiogram (ECG)
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do pregnancy tests in women of childbearing potential
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 Comparator: Placebo arm Participants will take Finerenone matching placebo for 6 months. |
Other: Placebo
Oral
|
Outcome Measures
Primary Outcome Measures
- 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
- Number of participants with treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse event (TESAEs) [From baseline up to 7 months]
- Number of participants with Hyperkalaemia [From baseline up to 7 months]
Hyperkalemia will be an adverse events of special interest (AESI).
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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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:
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Circulating T1D-associated autoantibodies
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Hospitalization for diabetic ketoacidosis
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Plasma C-peptide below the limit of detection with standard assay (with concurrent blood glucose >100 mg/dl).
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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.
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K+ ≤ 4.8 mmol/L at Screening (local assessment)
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Participants with a clinical diagnosis of CKD and fulfilling both the criteria (central assessment):
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eGFR ≥25 and <90 mL/min/1.73 m^2 using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) 2009 formula at the Screening visit
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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)
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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:
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Participant with T2D (Type 2 diabetes).
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Participant with mean BP (Blood pressure) higher than 160/100 mmHg or mean systolic BP lower than 90 mmHg at the Screening visit
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Symptomatic heart failure with reduced ejection fraction with class 1A indication for Mineralocorticoid receptor antagonists (MRAs).
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford Health Care (SHC) | Stanford | California | United States | 94305-2200 |
| 2 | Touro University (TU) - College of Osteopathic Medicine (TUCOM) - California | Vallejo | California | United States | 94592-1118 |
| 3 | University of Colorado School of Medicine - Barbara Davis Center for Childhood Diabetes (BDC) | Aurora | Colorado | United States | 80045-2536 |
| 4 | Elixia Fort Lauderdale, LLC (Renal Electrolyte and Hypertension Consultants) | Orlando | Florida | United States | 32806 |
| 5 | Hanson Diabetes Center | Port Charlotte | Florida | United States | 33952-6722 |
| 6 | Jedidiah Clinical Research | Tampa | Florida | United States | 33617 |
| 7 | Metabolic Research Institute, Inc. | West Palm Beach | Florida | United States | 33401-3430 |
| 8 | Morehouse School of Medicine | Clinical Research Centre | Atlanta | Georgia | United States | 30303-3031 |
| 9 | Northwestern Medical Group (Northwestern Medical Faculty Foundation) | Chicago | Illinois | United States | 60611 |
| 10 | University of Iowa Hospitals & Clinics | Iowa City | Iowa | United States | 52242 |
| 11 | Tulane Medical Center (TMC) - Tulane Lakeside Specialty Clinic | Metairie | Louisiana | United States | 70001-1210 |
| 12 | Omega Clinical Research Center | Metairie | Louisiana | United States | 70006 |
| 13 | MedStar Good Samaritan Hospital - MedStar Medical Group Internal Medicine | Baltimore | Maryland | United States | 21239-2945 |
| 14 | University of Missouri Health Care | Columbia | Missouri | United States | 65212 |
| 15 | Washington University School of Medicine in St. Louis | Saint Louis | Missouri | United States | 63110-1010 |
| 16 | Cleveland Clinic - Main Campus | Cleveland | Ohio | United States | 44195-0001 |
| 17 | Unc Endocrinology At Eastowne Unc Hospitals Outpat | Chapel Hill | South Carolina | United States | 27514 |
| 18 | Physicians East, P.A. - Endocrinology | Greenville | South Carolina | United States | 27834-5051 |
| 19 | Carolina Health Specialists - Medical Complex - 82nd Parkway Location | Myrtle Beach | South Carolina | United States | 29572-4610 |
| 20 | Eastern Virginia Medical School (EVMS) - Strelitz Diabetes Center | Norfolk | Virginia | United States | 23510 |
| 21 | Aalborg Universitetshospital | Aalborg | Denmark | 9000 | |
| 22 | Sydvestjysk Sygehus - Esbjerg | Esbjerg | Denmark | 6700 | |
| 23 | Steno Diabetes Center Copenhagen | Herlev | Denmark | 2730 | |
| 24 | Nordsjaellands Hospital - Hillerod | Hillerod | Denmark | 3400 | |
| 25 | Holstebro Hospital, Endocrinology dept. | Holstebro | Denmark | DK-7500 | |
| 26 | Odense Universitetshospital, Endokrinologisk Afd. M | Odense C | Denmark | 5000 | |
| 27 | InnoDiab Forschung GmbH | Essen | Nordrhein-Westfalen | Germany | 45136 |
| 28 | Ruhr-Universitaet Bochum - Herz und Diabeteszentrum NRW (Heart and Diabetes Center) | Bad Oeynhausen | Germany | 32545 | |
| 29 | A.O.U. di Bologna Policlinico S.Orsola Malpighi | Bologna | Emilia-Romagna | Italy | 40138 |
| 30 | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | Lazio | Italy | 00161 |
| 31 | A.O.U. Careggi | Firenze | Toscana | Italy | 50134 |
| 32 | ASST Papa Giovanni XXIII (Azienda Ospedaliera Papa Giovanni XXIII) | Bergamo | Italy | 24127 | |
| 33 | Azienda Sanitaria Locale TO 5 - Ospedale Maggiore Chieri | Chieri | Italy | 10023 | |
| 34 | Università degli Studi "G. D'Annunzio" Chieti - Endocrinologia | Chieti | Italy | 66100 | |
| 35 | Ospedale FBF e Oftalmico Milano | Milano | Italy | 20157 | |
| 36 | Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele) | Milan | Italy | 20132 | |
| 37 | ASST Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario | Milan | Italy | 20142 | |
| 38 | Seoul National University Hospital | Seoul | Seoul Teugbyeolsi | Korea, Republic of | 03080 |
| 39 | Korea University Anam Hospital | Seoul | Korea, Republic of | 02841 | |
| 40 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
| 41 | Complejo Hospitalario Universitario A Coruna (CHUAC) | A Coruna | Spain | 15006 | |
| 42 | Hospital Clínic i Provincial de Barcelona | Barcelona | Spain | 8036 | |
| 43 | Hospital Vithas Sevilla | Castilleja de la Cuesta | Spain | 41950 | |
| 44 | Hospital General Universitario Gregorio Maranon (HGUGM) | Madrid | Spain | 28007 | |
| 45 | Universidad Autonoma de Madrid (UAM) - Hospital Universitario Puerta de Hierro - Majadahonda | Majadahonda | Spain | 28222 | |
| 46 | Servicio Andaluz de Salud (SAS) - Hospital Universitario Virgen de la Victoria (HUVV) | Malaga | Spain | 29010 | |
| 47 | Royal London Hospital | London | United Kingdom | E1 1BB |
Sponsors and Collaborators
- Bayer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 22267
- 2022-503024-27-00