Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function

Poitiers University Hospital329 enrolled

Overview

Prospective, multicenter, randomized and open label study evaluating the benefit on renal function at 12 months post-transplantation, with an immunosuppression without calcineurin inhibitor at 3 months and combining mycophenolate sodium-Everolimus versus an immunosuppression combining Everolimus-Tacrolimus, in de novo renal transplant patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

329

Conditions

Chronic Kidney Disease

Interventions

EverolimusDRUG

Active Comparator

TacrolimusDRUG

Active Comparator

Mycophenolate sodiumDRUG

Experimental Arm

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients receiving a first kidney transplant from a cadaveric or living donor Exclusion Criteria: * Double transplant * Patient who has been treated with an immunosuppressive drug or study drug during the four weeks before administration of the first dose of Everolimus

Locations (14)

Amiens University Hospital

Amiens, France

Angers University Hospital

Angers, France

Brest University Hospital

Brest, France

Outcomes

Primary Outcomes

Renal function as measured by estimated glomerular filtration rate GFR

GFR unit : mL / min / 1.73 m2

Time frame: One year after inclusion

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.