Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function
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.
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: May 31, 2019
Interventions
- Drug: Everolimus
- Active Comparator
- Drug: Tacrolimus
- Active Comparator
- Drug: Mycophenolate sodium
- Experimental Arm
Arms, Groups and Cohorts
- Active Comparator: 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).
- Experimental: 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.
Clinical Trial Outcome Measures
Primary Measures
- Renal function as measured by estimated glomerular filtration rate GFR
- Time Frame: One year after inclusion
- GFR unit : mL / min / 1.73 m2
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Poitiers University Hospital
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Antoine THIERRY, MD, Principal Investigator, Poitiers University Hospital
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