FINERENONE for Chronic kidney disease

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 and ≤ 75 years"}
• {"criterion_text":"- eGFR ≥ 25 mL/min/1.73m2"}
• {"criterion_text":"- UACR > 100 mg/g (10 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."}
• {"criterion_text":"- Participants must be on a maximum tolerated dose of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) for at least four weeks before enrollment."}
• {"criterion_text":"- Ability to communicate with the study staff and understand and sign the informed consent."}

Exclusion criteria

• {"criterion_text":"- Age < 18 years or > 75 years"}
• {"criterion_text":"- Eligible to receive at least two of three study treatments. Participants meeting two or more of the following criteria will be excluded: a.\tPotassium > 5.0 mmol/L b.\tHeart failure NYHA class III or IV or NT-proBNP > 600 pg/ml c.\tNot a candidate for treatment with an SGLT2 inhibitor, e.g., due to contraindications (according to the Forxiga SmPC) or previously experienced side effects from an SGLT2 inhibitor."}
• {"criterion_text":"- NT-proBNP > 1200 pg/ml"}
• {"criterion_text":"- Severe peripheral or facial edema (according to the investigator's opinion)"}
• {"criterion_text":"- Diagnosis of unstable angina pectoris and/or myocardial infarction within the last six months."}
• {"criterion_text":"- Already receiving treatment with two of the three study drugs (for example, an SGLT2 inhibitor and finerenone)."}
• {"criterion_text":"- Treatment with a potassium-sparing diuretic or a mineralocorticoid receptor antagonist, except for finerenone (e.g., spironolactone, eplerenone, or amiloride)"}
• {"criterion_text":"- Elevated Alanine Aminotransferase (ALT) > 3 x upper normal limit, 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.)"}
• {"criterion_text":"- Autosomal dominant or autosomal recessive polycystic kidney disease"}
• {"criterion_text":"- Lupus nephritis or ANCA-associated vasculitis, or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening"}
• {"criterion_text":"- Kidney transplant"}
• {"criterion_text":"- Dialysis"}
• {"criterion_text":"- Addison's disease"}
• {"criterion_text":"- Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, cobicistat, clarithromycin)"}
• {"criterion_text":"- Idiopathic pulmonary fibrosis"}
• {"criterion_text":"- Type 1 diabetes"}
• {"criterion_text":"- Known or suspected hypersensitivity to the study medications or related products"}
• {"criterion_text":"- Presence or history of malignant neoplasms (except basal cell skin cancer or squamous cell skin cancer) within 5 years before screening."}
• {"criterion_text":"- Any other history, condition, therapy, or uncontrolled intercurrent illness that could, as judged by the investigator, affect participant safety or compliance with study requirements."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Participant in another intervention study."}

Primary endpoints

• {"endpoint_text":"- Between-group comparison of the change in albuminuria (UACR) from baseline (randomization) to week 36.","definition_or_measurement_approach":"Change in albuminuria measured by urinary albumin-to-creatinine ratio (UACR) from baseline (randomization) to week 36 (between-group comparison)."}

Secondary endpoints

• {"endpoint_text":"- Between-group comparison of the change in eGFR from 1) week 16 to week 64 2) baseline to week 64 3) baseline to week 66","definition_or_measurement_approach":"Change in estimated glomerular filtration rate (eGFR) between the specified timepoints (week 16 to week 64; baseline to week 64; baseline to week 66)."}
• {"endpoint_text":"- To have developed a communication tool at the end of the study that can instruct patients and healthcare professionals about using biomarker-guided treatment.","definition_or_measurement_approach":"Development and implementation of a communication tool; assessment of the tool's completion and its ability to instruct patients and healthcare professionals as described in study objectives."}
• {"endpoint_text":"- Between-group comparison of the change in KidneyIntelX score from baseline to week 36.","definition_or_measurement_approach":"Change in KidneyIntelX score from baseline to week 36 (between-group comparison)."}

Denmark

Earliest CTIS Part Ii Submission Date

13-05-2024

Latest Decision Or Authorization Date

04-06-2024

Processing Time Days

22

Number Of Sites

1

Number Of Participants

40

Germany

Earliest CTIS Part Ii Submission Date

29-04-2024

Latest Decision Or Authorization Date

07-06-2024

Processing Time Days

39

Number Of Sites

1

Number Of Participants

10

Italy

Earliest CTIS Part Ii Submission Date

12-05-2024

Latest Decision Or Authorization Date

06-06-2024

Processing Time Days

25

Number Of Sites

2

Number Of Participants

45

Spain

Earliest CTIS Part Ii Submission Date

29-02-2024

Latest Decision Or Authorization Date

04-06-2024

Processing Time Days

96

Number Of Sites

1

Number Of Participants

15

Sweden

Earliest CTIS Part Ii Submission Date

07-05-2024

Latest Decision Or Authorization Date

05-06-2024

Processing Time Days

29

Number Of Sites

1

Number Of Participants

5

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":"code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}