Prospective Multicenter Randomized Openlabel Study to Evaluate the Benefit on Renal Function at 12months Post-transplantation of Immunosuppressive Treatment With Withdrawal of Calcineurin Inhibitor at 3months and Combining Mycophenolate Sodium-Everolimus Versus Tacrolimus-Everolimus, in Patients With de Novo Kidney Transplant
Overview
- Phase
- Phase 3
- Intervention
- Everolimus
- Conditions
- Chronic Kidney Disease
- Sponsor
- Poitiers University Hospital
- Enrollment
- 329
- Locations
- 14
- Primary Endpoint
- Renal function as measured by estimated glomerular filtration rate GFR
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Everolimus-Tacrolimus
* Tacrolimus (Prograf®) started at 0,1 mg/kg/day since Day0, then adapted to C0 concentration (4-7 ng/ml), * Everolimus (Certican®) started within 24h after reperfusion, to be adapted to C0 concentration (3-8 ng/ml).
Intervention: Everolimus
Everolimus-Tacrolimus
* Tacrolimus (Prograf®) started at 0,1 mg/kg/day since Day0, then adapted to C0 concentration (4-7 ng/ml), * Everolimus (Certican®) started within 24h after reperfusion, to be adapted to C0 concentration (3-8 ng/ml).
Intervention: Tacrolimus
Everolimus-Mycophenolate sodium
* Everolimus (Certican®) started within 24h after reperfusion, to be adapted to C0 concentration (3-8 ng/ml), * Tacrolimus (Prograg®) started at 0,1 mg/kg/day from J0 then to be adapted to C0 concentration (4-7 ng/ml), then replacement by mycophenolate sodium (Myfortic®) at M3 (3 months visit) started at 1440 mg/day.
Intervention: Everolimus
Everolimus-Mycophenolate sodium
* Everolimus (Certican®) started within 24h after reperfusion, to be adapted to C0 concentration (3-8 ng/ml), * Tacrolimus (Prograg®) started at 0,1 mg/kg/day from J0 then to be adapted to C0 concentration (4-7 ng/ml), then replacement by mycophenolate sodium (Myfortic®) at M3 (3 months visit) started at 1440 mg/day.
Intervention: Mycophenolate sodium
Outcomes
Primary Outcomes
Renal function as measured by estimated glomerular filtration rate GFR
Time Frame: One year after inclusion
GFR unit : mL / min / 1.73 m2