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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