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

Phase 3

Completed

• Conditions: Renal Transplant
• Interventions: Drug: Anti R-IL2 + Cyclosporine; Drug: Anti R-IL2 + Cyclosporine then Everolimus; Drug: Thymoglobulin + Everolimus

• Registration Number: NCT01028092
• Lead Sponsor: University Hospital, Brest

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-12-08
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Primary Completion: 2014-03
• Status Verified: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-07
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 327

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Anti R-IL2 + Cyclosporine	anti R-IL2 induction + Mycophenolate Mofetil + cyclosporine A + corticosteroids
Switch	Anti R-IL2 + Cyclosporine then Everolimus	anti R-IL2 + Mycophenolate Mofetil + (Cyclosporine then Everolimus) + corticosteroids
CNI-free	Thymoglobulin + Everolimus	Thymoglobulin + Mycophenolate Mofetil + everolimus + corticosteroids

Primary Outcome Measures

Name	Time	Method
calculated renal function with MDRD equation	12 months

Secondary Outcome Measures

Name	Time	Method
Acute rejection rate	12 months
GFR calculated with Cockcroft Gault formula	12 months
Patient and graft survival rate	12 months
Adverse events	12 months

Trial Locations

Locations (18)

CHU Pellegrin - Bordeaux; 🇫🇷 Bordeaux, France

CHU Cote de Nacre; 🇫🇷 Caen, France

CHU Limoges; 🇫🇷 Limoges, France

AP-HP Hopital Necker; 🇫🇷 Paris, France

CHU Reims; 🇫🇷 Reims, France

Hopitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

CHU Dijon; 🇫🇷 Dijon, France

CHU Lille; 🇫🇷 Lille, France

CHU Amiens; 🇫🇷 Amiens, France

CHRU de BREST; 🇫🇷 Brest, France

CHU Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

CHU Montpellier; 🇫🇷 Montpellier, France

CHU Nice; 🇫🇷 Nice, France

CHU Poitiers; 🇫🇷 Poitiers, France

CHU Tours; 🇫🇷 Tours, France

CHU Rennes; 🇫🇷 Rennes, France

CHU Rouen; 🇫🇷 Rouen, France

CHU Rangueil - Toulouse; 🇫🇷 Toulouse, France