EPLERENONE for End-stage renal disease|Renal transplantation

Inclusion criteria

• {"criterion_text":"- Patients older than 18 years of age\n- Informed consent\n- Candidate for a single or a dual kidney transplantation from an expanded criteria deceased donor ( 60 years or older or age between 50 and 59 with 2 of the 3 following criteria: cardiovascular death, history of hypertension, serum creatinine above 130μmol/L), regardless of machine perfusion and graft rank\n- Chronic hemodialysis\n- Affiliated to a social security system"}

Exclusion criteria

• {"criterion_text":"- Multiple organ transplantation (kidney and liver, kidney and heart, kidney and pancreas, kidney and lung, kidney and intestine)\n- Preemptive transplantation\n- Hypersensitivity or known allergy to Eplerenone or one of its excipients\n- Patients with severe hepatic insufficiency (class Child-Pugh C)\n- Patient receiving powerful CYP3A4 inhibitors (for example itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycyn and nefazodone)\n- Hypersensitivity or known allergy to iodinated contrast agents (iohexol)\n- Demonstrated thyrotoxicosis\n- Hypersensitivity to lactose\n- HLA desensitization prior to renal transplantation\n- Pregnant woman or woman without effective contraception\n- Patient under judicial protection\n- Patient under legal guardianship\n- Participation in another biomedical study\n- Patient receiving a graft from a donor under mineralocorticoid receptor antagonist treatment (spironolactone or eplerenone)\n- Peritoneal dialysis"}

Primary endpoints

• {"endpoint_text":"- Iohexol clearance at 3 months","definition_or_measurement_approach":"Measured as iohexol clearance (assessment of glomerular filtration rate) at 3 months post-kidney transplantation."}

Secondary endpoints

• {"endpoint_text":"- Proportion of dialysis dependency at 3 months\n- Proportion of patients presenting a delayed graft function at 7 days post transplantation\n- 24-hour proteinuria and 24-hour microalbuminuria at 3 months\n- Occurrence of hyperkalemia > 6 mmol/l at 7 days post transplantation\n- Length of initial hospital stay\n- Proportion of patients alive and glomerular filtration rate at 3 months 1 year, 3 years, 10 years post transplantation\n- Proportion of patients with biopsy-proven acute rejection at 3 months post tranplantation","definition_or_measurement_approach":"Proportion of dialysis dependency at 3 months: evaluated by frequency of need for dialysis determined by treating nephrologist and/or iohexol clearance < 30 mL/min/1.73m² at 3 months. Proportion presenting delayed graft function at 7 days: defined by need for dialysis within 7 days post-transplant; categories of immediate/intermediate/delayed graft function defined by serum creatinine thresholds at 7 days. 24-hour proteinuria and 24-hour microalbuminuria at 3 months: quantified in g/24h and mg/24h respectively. Occurrence of hyperkalemia > 6 mmol/l at 7 days: frequency of non-hemolysed blood samples with K+ > 6 mmol/L during the first week post-transplant. Length of initial hospital stay: measured in days. Proportion alive and GFR at specified timepoints: obtained from CRISTAL database for vital status and creatinine with eGFR estimated by CKD-EPI at 3 months, 1 year, 3 years, and 10 years. Proportion with biopsy-proven acute rejection at 3 months: proportion of patients with biopsy-confirmed acute rejection within first 3 months."}

France

Earliest CTIS Part Ii Submission Date

29-10-2024

Latest Decision Or Authorization Date

28-11-2024

Processing Time Days

30

Number Of Sites

7

Number Of Participants

132

Primary sponsor

Full Name

CHRU De Nancy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France