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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Brest
• Collaborators: Genzyme, a Sanofi Company; Ministry of Health, France; Novartis; Roche Pharma AG
• Treatments: Cyclosporine; Cyclosporins; Everolimus; Immunosuppressive Agents; Interleukin-2; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus; Thymoglobulin

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)