FINERENONE for Chronic kidney disease

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 and ≤ 75 years\n- UACR 100-5000 mg/g (11.3-565 mg/mmol) in two consecutive first-morning void urine samples. (UACR 80-100 mg/g is accepted if historical measurements are above 100 mg/g and if it cannot be explained by any new treatment.)\n- Stable treatment with maximum tolerated dose of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker for at least four weeks prior to randomization. (Unless such treatment is contraindicated or not tolerated.)\n- Ability to communicate with the study staff and understand and sign the informed consent."}

Exclusion criteria

• {"criterion_text":"- eGFR < 25 mL/min/1.73m2 at screening (FOR ITALY ONLY: eGFR < 30 and eGFR > 60 mL/min/1.73m2 at screening.)\n- Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, cobicistat, clarithromycin)\n- Treatment with a potassium-sparing diuretic or a mineralocorticoid receptor antagonist, except for finerenone (e.g., spironolactone, eplerenone, or amiloride)\n- Elevated Alanine Aminotransferase (ALT) > 3 x upper normal limit at screening, autoimmune hepatitis, and/or severe hepatic impairment (including but not limited to a history of hepatic encephalopathy, a history of esophageal varices or a history of portocaval shunt.)\n- Autosomal dominant or autosomal recessive polycystic kidney disease\n- Lupus nephritis or ANCA-associated vasculitis, or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening\n- Kidney transplant or dialysis\n- Known or suspected hypersensitivity to the study medications or related products\n- Presence or history of malignant neoplasms (except basal cell skin cancer or squamous cell skin cancer) within five years before screening.\n- Any other history, condition, therapy, or uncontrolled intercurrent illness that could, as judged by the investigator, affect participant safety or compliance with study requirements.\n- A female who is pregnant, breastfeeding, or intends to become pregnant, or women of childbearing potential (WOCBP) who are not using highly effective contraceptive methods.\n- Treatment with two or all of the three study drugs\n- Known or suspected abuse of narcotics\n- Participant in another intervention study.\n- Vulnerable (i.e. under guardianship) or mentally incapacitated subjects (i.e. not able to understand and sign the informed consent).\n- History of pancreatitis at screening\n- Body mass index < 18.5 kg/m2 at screening\n- Type 1 diabetes\n- Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrolment\n- NYHA class IV Congestive Heart Failure at screening\n- Serum potassium > 5.0 mmol/L at screening\n- Addison’s Disease"}

Primary endpoints

• {"endpoint_text":"- Chronic eGFR slope, defined as mean annual rate of change in eGFR from week 26 to week 104.","definition_or_measurement_approach":"Mean annual rate of change in estimated glomerular filtration rate (eGFR) measured from week 26 to week 104."}

Secondary endpoints

• {"endpoint_text":"- Change in eGFR from baseline to week 112 (end of study).","definition_or_measurement_approach":"Absolute change in eGFR from baseline to week 112 (end of study)."}
• {"endpoint_text":"- Change in eGFR from baseline to week 104 (end of treatment).","definition_or_measurement_approach":"Absolute change in eGFR from baseline to week 104 (end of treatment)."}
• {"endpoint_text":"- Change in albuminuria from baseline to week 104.","definition_or_measurement_approach":"Change in urinary albumin (albuminuria) from baseline to week 104."}
• {"endpoint_text":"- Change in KidneyIntelX score from baseline to week 104.","definition_or_measurement_approach":"Change in KidneyIntelX risk score from baseline to week 104."}
• {"endpoint_text":"- FOR ITALY ONLY: Change in UEGF from baseline to week 26 and association between change in uEGF and change in albuminuria (Exploratory endpoint)","definition_or_measurement_approach":"Change in urinary EGF (uEGF) from baseline to week 26 and correlation/association analyses between change in uEGF and change in albuminuria (exploratory, Italy only)."}

Methods

• Recruitment letters (country-specific recruitment letter templates referenced: e.g., 'Forside til rekrutteringsbrev') targeting patients with chronic kidney disease.
• Flyers and posters (documents titled 'Flyer' and 'poster') to be used in clinical sites and public announcements targeted to patients with chronic kidney disease.
• Announcements and 'TrialTree' materials (documents titled 'announcement' and 'TrialTree') to inform potential participants and collaborators.
• Country-specific recruitment arrangements documents (K1/K2) and collaboration with partner organisations (documents reference cooperating partners). Documents available for Denmark, Spain, Germany, Italy and Sweden.

Sweden

Earliest CTIS Part Ii Submission Date

17-03-2025

Latest Decision Or Authorization Date

30-07-2025

Processing Time Days

135

Number Of Sites

1

Number Of Participants

5

Spain

Earliest CTIS Part Ii Submission Date

06-01-2025

Latest Decision Or Authorization Date

29-07-2025

Processing Time Days

204

Number Of Sites

1

Number Of Participants

15

Germany

Earliest CTIS Part Ii Submission Date

21-03-2025

Latest Decision Or Authorization Date

29-07-2025

Processing Time Days

130

Number Of Sites

1

Number Of Participants

10

Italy

Earliest CTIS Part Ii Submission Date

12-01-2026

Latest Decision Or Authorization Date

05-03-2026

Processing Time Days

52

Number Of Sites

2

Number Of Participants

45

Denmark

Earliest CTIS Part Ii Submission Date

17-03-2025

Latest Decision Or Authorization Date

08-04-2026

Processing Time Days

387

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Steno Diabetes Center Copenhagen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"Sponsor duties (code 1)","organisation_type":"Hospital/Clinic/Other health care facility"}