FINERENONE for Chronic kidney disease

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- Known chronic kidney disease from any cause (eGFR ≥25 mL/min/1.73m2)"}
• {"criterion_text":"- Eligible for randomisation in at least one recruiting domain specific appendix"}
• {"criterion_text":"- Urine albumin-creatinine ratio (uACR) >200 mg/g (22.6 mg/mmol) or urine protein-creatinine ratio (uPCR) >300 mg/g (33.9 mg/mmol) from the most recent result in the previous 3 months"}
• {"criterion_text":"- On a stable standard of care treatment for CKD, including a SGLT2i unless there is a documented reason not to be using a SGLT2i, for 4 weeks before screening according to treating physician."}
• {"criterion_text":"- Treating physician believes finerenone is clinically appropriate for the participant"}
• {"criterion_text":"- Currently receiving standard of care treatment according to treating physician"}
• {"criterion_text":"- Participant and treating physician are willing and able to perform trial Core procedures and MRA DSA procedures"}
• {"criterion_text":"- Provision of written informed consent or eConsent prior to peforming any Core protocol and MRA DSA related procedures"}

Exclusion criteria

• {"criterion_text":"- Currently receiving maintenance dialysis"}
• {"criterion_text":"- Severe hepatic impairment (defined as Child-Pugh Class C)"}
• {"criterion_text":"- Adrenal insufficiency"}
• {"criterion_text":"- Currently pregnant or breast feeding, or intending to become pregnant"}
• {"criterion_text":"- Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months"}
• {"criterion_text":"- Life expectancy less than 6 months"}
• {"criterion_text":"- Recipient of kidney transplant"}
• {"criterion_text":"- Hyperkalaemia (serum potassium ≥5.0 mmol/L) at time of screening"}
• {"criterion_text":"- Current treatment with an mineralocorticoid receptor antagonist, where the treating physician or patient is not willing to discontinue this medication"}
• {"criterion_text":"- Known allergy, intolerance or contraindication to MRAs"}
• {"criterion_text":"- Current treatment with strong CYP3A4 inhibitors"}
• {"criterion_text":"- Systolic BP <110 mmHg or diastolic BP <55 mmHg without antihypertensive therapy at time of screening"}

Primary endpoints

• {"endpoint_text":"- Chronic eGFR slope estimated from all available eGFR values from week 4 to week 104","definition_or_measurement_approach":"Estimated chronic eGFR slope using all available eGFR values from week 4 through week 104."}

Secondary endpoints

• {"endpoint_text":"- Change in albuminuria as measured by uACR (or uPCR if uACR unavailable) between randomisation and 24 weeks, measured as a continuous variable","definition_or_measurement_approach":"Change in albuminuria measured by uACR (or uPCR if uACR unavailable) from randomisation to 24 weeks, analysed as a continuous variable."}
• {"endpoint_text":"- Composite outcome of proportion of participants experiencing a ≥40% eGFR decline between randomisation and 108 weeks, and proportion of participants developing kidney failure (defined as eGFR <15 mL/min/1.73m^2 or chronic kidney replacement therapy start) at 108 weeks","definition_or_measurement_approach":"Composite endpoint: proportion with ≥40% eGFR decline between randomisation and 108 weeks and proportion developing kidney failure (eGFR <15 mL/min/1.73m2 or start of chronic kidney replacement therapy) at 108 weeks."}
• {"endpoint_text":"- Time to a composite outcome of ≥40% eGFR decline from randomisation or kidney failure","definition_or_measurement_approach":"Time-to-event analysis for first occurrence of composite of ≥40% eGFR decline from randomisation or kidney failure."}
• {"endpoint_text":"- All-cause mortality at 108 weeks","definition_or_measurement_approach":"All-cause mortality assessed at 108 weeks post-randomisation."}
• {"endpoint_text":"- Proportion of participants experiencing one or more cardiovascular events (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke) between randomisation and 108 weeks","definition_or_measurement_approach":"Proportion experiencing any of the specified cardiovascular events between randomisation and 108 weeks."}
• {"endpoint_text":"- Time to first occurrence of a cardiovascular event","definition_or_measurement_approach":"Time-to-event analysis for first occurrence of a cardiovascular event (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke)."}
• {"endpoint_text":"- Safety and tolerability of treatment","definition_or_measurement_approach":"Assessment of safety and tolerability via reported adverse events and clinical/laboratory monitoring (specific safety measures not detailed in provided data)."}
• {"endpoint_text":"- Change in quality of life measured using the Quality of Life Impact Survey for Kidney Disease (QDIS-CKD) at 6-monthly intervals from randomisation to week 108","definition_or_measurement_approach":"Change in QDIS-CKD scores at 6-monthly intervals from randomisation up to week 108."}
• {"endpoint_text":"- The Mineralocorticoid Receptor Antagonist Domain-Specific Appendix has a domain-specific secondary outcome of time to the composite of ≥57% eGFR decline or kidney failure","definition_or_measurement_approach":"Domain-specific secondary outcome in MRA DSA: time to composite of ≥57% eGFR decline or kidney failure."}
• {"endpoint_text":"- Change in eGFR from randomisation to end of washout","definition_or_measurement_approach":"Change in eGFR measured from randomisation to the end of the washout period."}

Spain

Earliest CTIS Part Ii Submission Date

14-05-2025

Latest Decision Or Authorization Date

16-09-2025

Processing Time Days

125

Number Of Sites

9

Number Of Participants

150

Greece

Earliest CTIS Part Ii Submission Date

18-03-2026

Latest Decision Or Authorization Date

09-04-2026

Processing Time Days

22

Number Of Sites

10

Number Of Participants

100

Primary sponsor

Full Name

The George Institute For Global Health

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Australia