mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation

Overview

This study is designed to evaluate efficacity and safety of everolimus or (cyclosporine then everolimus) vs. cyclosporine as immunosuppressive treatment in renal transplantation for elderly (>60 years old) recipients receiving graft from elderly donor(>60 years old).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2014

Interventions

  • Drug: Anti R-IL2 + Cyclosporine
    • anti R-IL2 induction (Simulect ®, 20 mg D0 and D4) Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0 cyclosporine A (Neoral ®) started from 6 to 8 mg/kg adjusted to C2 corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6
  • Drug: Thymoglobulin + Everolimus
    • Thymoglobulin ® induction started at 1.5mg/kg/j then adjusted to CD2 or total lymphocytes count, for 5 days Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0 everolimus (Certican ®): 4 to 6 mg/day started at D5, adjusted to achieve a residual level between 6 et 10 ng/ml corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6
  • Drug: Anti R-IL2 + Cyclosporine then Everolimus
    • anti R-IL2 induction (Simulect ®, 20 mg D0 and D4) Mycophenolate Mofetil (Cellcept ®) 3 g/d beginning at D0 cyclosporine A (Neoral ®) beginning at 6 to 8 mg/kg adjusted to C2, then switch to everolimus (Certican ®) between at W6, started at 3 mg/d, then adjusted to achieve a residual level between 6 et 10 ng/ml corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6

Arms, Groups and Cohorts

  • Active Comparator: Control
    • anti R-IL2 induction + Mycophenolate Mofetil + cyclosporine A + corticosteroids
  • Experimental: CNI-free
    • Thymoglobulin + Mycophenolate Mofetil + everolimus + corticosteroids
  • Experimental: Switch
    • anti R-IL2 + Mycophenolate Mofetil + (Cyclosporine then Everolimus) + corticosteroids

Clinical Trial Outcome Measures

Primary Measures

  • calculated renal function with MDRD equation
    • Time Frame: 12 months

Secondary Measures

  • Acute rejection rate
    • Time Frame: 12 months
  • Patient and graft survival rate
    • Time Frame: 12 months
  • Adverse events
    • Time Frame: 12 months
  • GFR calculated with Cockcroft Gault formula
    • Time Frame: 12 months

Participating in This Clinical Trial

Inclusion Criteria

  • Patient who has given written informed consent to participate in the study
  • First or second single transplantation of a recipient (male or female) older than 60 years old
  • Donor older than 60 years old
  • PRA < 30%

Exclusion Criteria

  • Living donor
  • Third transplantation
  • PRA > 30%

Other protocol-defined inclusion/exclusion criteria may apply.

  • Recipient of multi-organ transplant
  • Active major infections (HBV, HCV, HIV)
  • Loss of a first graft for immunologic issues
  • Anemia (<9g/l) or leucopenia (<2500/mm3)

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Brest
  • Collaborator
    • Novartis
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yannick LE MEUR, MD/PhD, Principal Investigator, CHU de Brest

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