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

R

Regional University Hospital Center (CHRU)

Status and phase

Completed
Phase 3

Conditions

Renal Transplant

Treatments

Drug: Anti R-IL2 + Cyclosporine then Everolimus
Drug: Thymoglobulin + Everolimus
Drug: Anti R-IL2 + Cyclosporine

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01028092
RB 09.074
EVEROLD

Details and patient eligibility

About

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).

Enrollment

327 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

327 participants in 3 patient groups

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

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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