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

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)

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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