Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)

Central Hospital, Nancy, France

Status and phase: Active, not recruiting; Phase 3

Conditions: End-stage Renal Disease

Treatments: Drug: Eplerenone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02490904

2015-000956-29

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 2 patient groups, including a placebo group

Eplerenone group

Experimental group

Description:

Eplerenone administration within 2 hours prior to patient departure to the operating room and for 4 days after kidney transplantation.

Treatment:

Drug: Eplerenone

Placebo group

Placebo Comparator group

Description:

Placebo administration within 2 hours prior to patient departure to the operatingroom and for 4 days after kidney transplantation

Treatment:

Drug: Placebo