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Clinical Trials/NCT01028092
NCT01028092
Completed
Phase 3

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

University Hospital, Brest18 sites in 1 country327 target enrollmentMarch 2009
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ConditionsRenal Transplant
InterventionsAnti R-IL2 + CyclosporineThymoglobulin + EverolimusAnti R-IL2 + Cyclosporine then Everolimus
DrugsAnti R-IL2 + CyclosporineThymoglobulin + EverolimusAnti R-IL2 + Cyclosporine then Everolimus

Overview

Phase
Phase 3
Intervention
Anti R-IL2 + Cyclosporine
Conditions
Renal Transplant
Sponsor
University Hospital, Brest
Enrollment
327
Locations
18
Primary Endpoint
calculated renal function with MDRD equation
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
July 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Arms & Interventions

Control

anti R-IL2 induction + Mycophenolate Mofetil + cyclosporine A + corticosteroids

Intervention: Anti R-IL2 + Cyclosporine

CNI-free

Thymoglobulin + Mycophenolate Mofetil + everolimus + corticosteroids

Intervention: Thymoglobulin + Everolimus

Switch

anti R-IL2 + Mycophenolate Mofetil + (Cyclosporine then Everolimus) + corticosteroids

Intervention: Anti R-IL2 + Cyclosporine then Everolimus

Outcomes

Primary Outcomes

calculated renal function with MDRD equation

Time Frame: 12 months

Secondary Outcomes

  • Acute rejection rate(12 months)
  • GFR calculated with Cockcroft Gault formula(12 months)
  • Adverse events(12 months)
  • Patient and graft survival rate(12 months)

Study Sites (18)

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