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

This study has been completed.
Sponsor:
Collaborators:
Novartis
Roche Pharma AG
Genzyme, a Sanofi Company
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01028092
First received: December 8, 2009
Last updated: July 7, 2014
Last verified: July 2014

December 8, 2009
July 7, 2014
March 2009
March 2014   (final data collection date for primary outcome measure)
calculated renal function with MDRD equation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01028092 on ClinicalTrials.gov Archive Site
  • Acute rejection rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Patient and graft survival rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • GFR calculated with Cockcroft Gault formula [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation
mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Transplant
  • 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
  • Active Comparator: Control
    anti R-IL2 induction + Mycophenolate Mofetil + cyclosporine A + corticosteroids
    Intervention: Drug: Anti R-IL2 + Cyclosporine
  • Experimental: CNI-free
    Thymoglobulin + Mycophenolate Mofetil + everolimus + corticosteroids
    Intervention: Drug: Thymoglobulin + Everolimus
  • Experimental: Switch
    anti R-IL2 + Mycophenolate Mofetil + (Cyclosporine then Everolimus) + corticosteroids
    Intervention: Drug: Anti R-IL2 + Cyclosporine then Everolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
327
July 2014
March 2014   (final data collection date for primary outcome measure)

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)
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01028092
EVEROLD, RB 09.074
Yes
University Hospital, Brest
University Hospital, Brest
  • Novartis
  • Roche Pharma AG
  • Genzyme, a Sanofi Company
  • Ministry of Health, France
Principal Investigator: Yannick LE MEUR, MD/PhD CHU de Brest
University Hospital, Brest
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP