Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)

End-stage Renal Disease Clinical Trial

— EPURE  

Official title:

Double-blind Placebo-Controlled Randomized Clinical Trial of Mineralocorticoid Receptor Blockade With Eplerenone After Renal Transplantation : Effect on Graft Function at 3 Months.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02490904
• Other study ID #: 2015-000956-29
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 19, 2016
• Est. completion date: August 2031

Study information

• Verified date: June 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 132
• Est. completion date: August 2031
• Est. primary completion date: November 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• Eplerenone
Double-blinded Eplerenone administered for 4 days at 25mg every 12 hours
• Placebo
Double-blinded Placebo administered for 4 days at 25mg every 12 hours

Locations

Country	Name	City	State
France	CHRU Besançon	Besancon
France	CHU Brest	Brest
France	CHU Dijon- Hôpital Bocage Central	Dijon
France	CHRU de Nancy	Nancy
France	CHU Reims-Hôpital Maison Blanche	Reims
France	CHU Saint Etienne	Saint-Étienne
France	NHC -CHRU Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iohexol clearance	Graft function at 3 months evaluated by GFR using iohexol clearance	3 months
Secondary	Proportion of dialysis dependency		3 months
Secondary	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	7 days post transplantation
Secondary	24-hour proteinuria		3 months
Secondary	Occurrence of hyperkalemia > 6 mmol/l		7 days post transplant
Secondary	Length of initial hospital stay	between transplantation and discharge	1 month
Secondary	Proportion of patients alive	vital status collected through the national database of organ recipients	3 months 1 year, 3 years, 10 years
Secondary	serum creatinine	using the enzymatic method	3 months 1 year, 3 years, 10 years
Secondary	glomerular filtration rate	estimation using the CKD-EPI formula (in mL/min/1.73m2)	3 months 1 year, 3 years, 10 years
Secondary	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	7 days post transplant
Secondary	Iohexol clearance < 30 mL/min/1,73m²		3 months
Secondary	24-hour microalbuminuria		3 months
Secondary	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	7 days post transplant
Secondary	Proportion of patients with biopsy-proven acute rejection	Proportion of patients with biopsy-proven acute rejection in the first three month after transplantation	3 months post transplant