FINERENONE for Chronic kidney disease

Inclusion criteria

• {"criterion_text":"- 1. Age ≥ 18 years\n- 2. Known chronic kidney disease from any cause (eGFR ≥25 mL/min/1.73m^2)\n- 3. Currently receiving standard of care treatment according to treating physician\n- 4. Eligible for randomisation in at least one recruiting domain-specific appendix\n- 5. Participant and treating physician are willing and able to perform trial procedures\n- 6. Urine albumin-creatinine ratio (uACR) >200 mg/g or urine protein-creatinine ratio (uPCR) >300 mg/g from the most recent result in the previous 3 months.\n- 7. 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.\n- 8. Treating physician believes finerenone is clinically appropriate for the participant.\n- 9. Participant and treating physician are willing and able to perform Mineralocorticoid Receptor Antagonist Domain-Specific Appendix procedures."}

Exclusion criteria

• {"criterion_text":"- 1. Currently receiving maintenance dialysis\n- 10. Severe hepatic impairment (defined as Child-Pugh Class C)\n- 11. Adrenal insufficiency\n- 12. Currently pregnant or breast feeding, or intending to become pregnant\n- 2. Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months\n- 3. Life expectancy less than 6 months\n- 4. Recipient of kidney transplant\n- 5. Hyperkalaemia (serum potassium ≥5.0 mmol/L) at time of screening\n- 6. Current treatment with mineralocorticoid receptor antagonist (MRA), where the treating physician or patient is not willing to discontinue this medication\n- 7. Known allergy, intolerance or contraindication to MRAs\n- 8. Current treatment with strong CYP3A4 inhibitors\n- 9. Systolic BP <110 mmHg or diastolic BP <55 mmHg without antihypertensive therapy at time of screening"}

Primary endpoints

• {"endpoint_text":"- eGFR slope calculated using eGFR values from randomisation to week 108","definition_or_measurement_approach":"Calculated using eGFR values from randomisation to week 108 (eGFR slope from randomisation to week 108)."}

Secondary endpoints

• {"endpoint_text":"- 1. 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":"Measured by uACR (or uPCR if uACR unavailable) between randomisation and 24 weeks, analysed as a continuous variable."}
• {"endpoint_text":"- 2. 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 of proportion with 40% eGFR decline between randomisation and 108 weeks, and proportion developing kidney failure (eGFR <15 mL/min/1.73m^2 or start of chronic kidney replacement therapy) at 108 weeks."}
• {"endpoint_text":"- 3. Time to a composite outcome of ≥40% eGFR decline from randomisation or kidney failure","definition_or_measurement_approach":"Time-to-event: time from randomisation to either ≥40% eGFR decline or kidney failure."}
• {"endpoint_text":"- 4. All-cause mortality at 108 weeks","definition_or_measurement_approach":"All-cause mortality assessed at 108 weeks."}
• {"endpoint_text":"- 5. 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 one or more specified cardiovascular events between randomisation and 108 weeks."}
• {"endpoint_text":"- 6. Time to first occurrence of a cardiovascular event","definition_or_measurement_approach":"Time-to-event: time from randomisation to first occurrence of a cardiovascular event."}
• {"endpoint_text":"- 7. Safety and tolerability of treatment","definition_or_measurement_approach":"Safety and tolerability assessed by standard safety monitoring (adverse events, laboratory tests) as described in protocol (no further detail available in provided data)."}
• {"endpoint_text":"- 8. 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":"Quality of life measured using QDIS-CKD at 6-monthly intervals from randomisation to week 108."}
• {"endpoint_text":"- 9. 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: time to composite of ≥57% eGFR decline or kidney failure (as defined in domain-specific appendix)."}

Italy

Earliest CTIS Part Ii Submission Date

14-08-2024

Latest Decision Or Authorization Date

14-11-2024

Processing Time Days

92

Number Of Sites

13

Number Of Participants

300

Primary sponsor

Full Name

The George Institute For Global Health

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Australia