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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
132
Double-blinded Eplerenone administered for 4 days at 25mg every 12 hours
Double-blinded Placebo administered for 4 days at 25mg every 12 hours
CHRU Besançon
Besançon, France
CHU Brest
Brest, France
CHU Dijon- Hôpital Bocage Central
Dijon, France
CHRU de Nancy
Nancy, France
Iohexol clearance
Graft function at 3 months evaluated by GFR using iohexol clearance
Time frame: 3 months
Proportion of dialysis dependency
Time frame: 3 months
Proportion of patients presenting a delayed graft function
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
Time frame: 7 days post transplantation
24-hour proteinuria
Time frame: 3 months
Occurrence of hyperkalemia > 6 mmol/l
Time frame: 7 days post transplant
Length of initial hospital stay
between transplantation and discharge
Time frame: 1 month
Proportion of patients alive
vital status collected through the national database of organ recipients
Time frame: 3 months 1 year, 3 years, 10 years
serum creatinine
using the enzymatic method
Time frame: 3 months 1 year, 3 years, 10 years
glomerular filtration rate
estimation using the CKD-EPI formula (in mL/min/1.73m2)
Time frame: 3 months 1 year, 3 years, 10 years
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CHU Reims-Hôpital Maison Blanche
Reims, France
CHU Saint Etienne
Saint-Etienne, France
NHC -CHRU Strasbourg
Strasbourg, France
Proportion of patients with immediate renal recovery,
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
Time frame: 7 days post transplant
Iohexol clearance < 30 mL/min/1,73m²
Time frame: 3 months
24-hour microalbuminuria
Time frame: 3 months
Proportion of patients with a slow renal recovery
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
Time frame: 7 days post transplant
Proportion of patients with biopsy-proven acute rejection
Proportion of patients with biopsy-proven acute rejection in the first three month after transplantation
Time frame: 3 months post transplant