End-stage Renal Disease
Conditions
Keywords
Kidney transplantation, Eplerenone
Brief summary
Assess the impact of eplerenone (initiated within 2 hours prior to patient departure to the operating room and administered for 4 days during the post-operative period) on graft function evaluated by the measurement of glomerular filtration rate at 3 months - variable strongly associated with long-term graft survival.
Interventions
DRUGEplerenone
Double-blinded Eplerenone administered for 4 days at 25mg every 12 hours
DRUGPlacebo
Double-blinded Placebo administered for 4 days at 25mg every 12 hours
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years of age * Informed consent * 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 * Chronic hemodialysis * Affiliated to a social security system
Exclusion criteria
* Multiple organ transplantation (kidney and liver, kidney and heart, kidney and pancreas, kidney and lung, kidney and intestine) * Patient receiving a graft from a donor under mineralocorticoid receptor antagonist treatment (spironolactone or eplerenone) * Peritoneal dialysis * Preemptive transplantation * Hypersensitivity or known allergy to Eplerenone or one of its excipients * Patients with severe hepatic insufficiency (class Child-Pugh C) * Patient receiving powerful CYP3A4 inhibitors (for example itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycyn and nefazodone) * Hypersensitivity or known allergy to iodinated contrast agents (iohexol) * Demonstrated thyrotoxicosis * Hypersensitivity to lactose * HLA desensitization prior to renal transplantation * Pregnant woman or woman without effective contraception * Patient under judicial protection * Patient under legal guardianship * Participation in another biomedical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Iohexol clearance | 3 months | Graft function at 3 months evaluated by GFR using iohexol clearance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients presenting a delayed graft function | 7 days post transplantation | The proportion of patients with a delayed graft function defined by the need for one or more dialysis sessions during the 7 days following transplantation |
| 24-hour proteinuria | 3 months | — |
| Occurrence of hyperkalemia > 6 mmol/l | 7 days post transplant | — |
| Length of initial hospital stay | 1 month | between transplantation and discharge |
| Proportion of patients alive | 3 months 1 year, 3 years, 10 years | vital status collected through the national database of organ recipients |
| serum creatinine | 3 months 1 year, 3 years, 10 years | using the enzymatic method |
| Proportion of dialysis dependency | 3 months | — |
| Proportion of patients with immediate renal recovery, | 7 days post transplant | The proportion of patients with an immediate renal recovery is defined by a serum creatinine lower than 30 mg/L at 7 days post-transplant |
| Iohexol clearance < 30 mL/min/1,73m² | 3 months | — |
| 24-hour microalbuminuria | 3 months | — |
| Proportion of patients with a slow renal recovery | 7 days post transplant | The proportion of patients with slow renal recovery is defined by serum creatinine above 30 mg/L at 7 days post-transplant without the need for dialysis |
| Proportion of patients with biopsy-proven acute rejection | 3 months post transplant | Proportion of patients with biopsy-proven acute rejection in the first three month after transplantation |
| glomerular filtration rate | 3 months 1 year, 3 years, 10 years | estimation using the CKD-EPI formula (in mL/min/1.73m2) |
Countries
France
Outcome results
None listed