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

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).

Study Overview

• Status: Completed
• Conditions: Renal Transplant
• Intervention / Treatment: Drug: Anti R-IL2 + Cyclosporine; Drug: Thymoglobulin + Everolimus; Drug: Anti R-IL2 + Cyclosporine then Everolimus

• Study Type: Interventional
• Enrollment (Actual): 327
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU Amiens
  • Bordeaux, France
    • CHU Pellegrin - Bordeaux
  • Brest, France, 29609
    • CHRU de Brest
  • Caen, France
    • Chu Cote de Nacre
  • Clermont Ferrand, France
    • Chu Clermont Ferrand
  • Dijon, France
    • CHU Dijon
  • Lille, France
    • CHU Lille
  • Limoges, France
    • CHU Limoges
  • Montpellier, France
    • CHU Montpellier
  • Nice, France
    • CHU Nice
  • Paris, France
    • AP-HP Hôpital Necker
  • Poitiers, France
    • CHU Poitiers
  • Reims, France
    • Chu Reims
  • Rennes, France
    • Chu Rennes
  • Rouen, France
    • CHU Rouen
  • Strasbourg, France
    • Hôpitaux Universitaires de Strasbourg
  • Toulouse, France
    • CHU Rangueil - Toulouse
  • Tours, France
    • CHU Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; anti R-IL2 induction + Mycophenolate Mofetil + cyclosporine A + corticosteroids	Drug: Anti R-IL2 + Cyclosporine; anti R-IL2 induction (Simulect ®, 20 mg D0 and D4); Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0; cyclosporine A (Neoral ®) started from 6 to 8 mg/kg adjusted to C2; corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6
Experimental: CNI-free; Thymoglobulin + Mycophenolate Mofetil + everolimus + corticosteroids	Drug: Thymoglobulin + Everolimus; Thymoglobulin ® induction started at 1.5mg/kg/j then adjusted to CD2 or total lymphocytes count, for 5 days; Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0; everolimus (Certican ®): 4 to 6 mg/day started at D5, adjusted to achieve a residual level between 6 et 10 ng/ml; corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6
Experimental: Switch; anti R-IL2 + Mycophenolate Mofetil + (Cyclosporine then Everolimus) + corticosteroids	Drug: Anti R-IL2 + Cyclosporine then Everolimus; anti R-IL2 induction (Simulect ®, 20 mg D0 and D4); Mycophenolate Mofetil (Cellcept ®) 3 g/d beginning at D0; cyclosporine A (Neoral ®) beginning at 6 to 8 mg/kg adjusted to C2, then switch to everolimus (Certican ®) between at W6, started at 3 mg/d, then adjusted to achieve a residual level between 6 et 10 ng/ml; corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
calculated renal function with MDRD equation	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	12 months
Acute rejection rate	12 months
Patient and graft survival rate	12 months
GFR calculated with Cockcroft Gault formula	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Collaborators: Novartis; Roche Pharma AG; Ministry of Health, France; Genzyme, a Sanofi Company
• Investigators: Principal Investigator: Yannick LE MEUR, MD/PhD, CHU de Brest

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: December 8, 2009
• First Submitted That Met QC Criteria: December 8, 2009
• First Posted (Estimate): December 9, 2009

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 7, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Calcineurin Inhibitors; Everolimus; Thymoglobulin; Cyclosporine; Cyclosporins; Interleukin-2
• Other Study ID Numbers: EVEROLD; RB 09.074