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

Information source: University Hospital, Brest
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Transplant

Intervention: Anti R-IL2 + Cyclosporine (Drug); Thymoglobulin + Everolimus (Drug); Anti R-IL2 + Cyclosporine then Everolimus (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University Hospital, Brest

Official(s) and/or principal investigator(s):
Yannick LE MEUR, MD/PhD, Principal Investigator, Affiliation: CHU de Brest

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: calculated renal function with MDRD equation

Secondary outcome:

Acute rejection rate

Patient and graft survival rate

Adverse events

GFR calculated with Cockcroft Gault formula

Eligibility

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

CHU Amiens, Amiens, France

CHU Pellegrin - Bordeaux, Bordeaux, France

CHRU de BREST, Brest 29609, France

CHU Cote de Nacre, Caen, France

CHU Clermont Ferrand, Clermont Ferrand, France

CHU Dijon, Dijon, France

CHU Lille, Lille, France

CHU Limoges, Limoges, France

CHU Montpellier, Montpellier, France

CHU Nice, Nice, France

AP-HP Hopital Necker, Paris, France

CHU Poitiers, Poitiers, France

CHU Reims, Reims, France

CHU Rennes, Rennes, France

CHU Rouen, Rouen, France

Hopitaux Universitaires de Strasbourg, Strasbourg, France

CHU Rangueil - Toulouse, Toulouse, France

CHU Tours, Tours, France

Additional Information

Starting date: March 2009
Last updated: July 7, 2014

Page last updated: August 23, 2015

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