Text Size

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

This study is currently recruiting participants.
Verified May 2013 by University Hospital, Brest
Sponsor:
Collaborators:
Novartis
Roche Pharma AG
Genzyme
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01028092
First received: December 8, 2009
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Renal Transplant
 Drug: Anti R-IL2 + Cyclosporine
Drug: Thymoglobulin + Everolimus
Drug: Anti R-IL2 + Cyclosporine then Everolimus
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • calculated renal function with MDRD equation [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute rejection rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Patient and graft survival rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • GFR calculated with Cockcroft Gault formula [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 306
Study Start Date: March 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028092

Contacts
Contact: Yannick Le Meur, MD/PhD +33.2.98.34.70.74 yannick.lemeur@chu-brest.fr

Locations
France
CHU Amiens Recruiting
Amiens, France
Contact: Gabriel Choukroun, MD/PhD         choukroun.gabriel@chu-amiens.fr    
CHU Angers Withdrawn
Angers, France, 49933
CHU Pellegrin - Bordeaux Recruiting
Bordeaux, France
Contact: Pierre Merville, MD/PhD         pierre.merville@chu-bordeaux.fr    
CHRU de BREST Recruiting
Brest, France, 29609
Contact: Yannick LE MEUR, PHD     +332 98 34 70 74        
Contact: Stéphanie BOUVIER     +332 98 34 70 61     nephro@chu-brest.fr    
CHU Cote de Nacre Recruiting
Caen, France
Contact: Bruno Hurault de Ligny, MD/PhD         huraultdeligny-b@chu-caen.fr    
CHU Clermont Ferrand Recruiting
Clermont Ferrand, France
Contact: Patrice de Teix, MD/PhD         pdeteix@chu-clermontferrand.fr    
CHU Dijon Recruiting
Dijon, France
Contact: Christiane Mousson, MD/PhD         christiane.mousson@chu-dijon.fr    
CHU Lille Recruiting
Lille, France
Contact: Christian Noel, MD/PhD         cnoel@chru-lille.fr    
CHU Limoges Recruiting
Limoges, France
Contact: Marie ESSIG, MD/PhD         marie.essig@chu-limoges.fr    
CHU Montpellier Recruiting
Montpellier, France
Contact: Georges Mourad, MD/PhD         g.mourad@chu-montpellier.fr    
CHU Nice Recruiting
Nice, France
Contact: Elisabeth Cassuto, MD/PhD     +33.4.92.03.77.36        
AP-HP Hopital Necker Recruiting
Paris, France
Contact: Christophe Legendre, MD/PhD         christophe.legendre@nck.aphp.fr    
AP HP Hôpital Saint-Louis Withdrawn
Paris, France, 75475
CHU Poitiers Recruiting
Poitiers, France
Contact: Guy Touchard, MD/PhD         g.touchard@chu-poitiers.fr    
CHU Reims Recruiting
Reims, France
Contact: Philippe Rieu, MD/PhD         prieu@chu-reims.fr    
CHU Rennes Recruiting
Rennes, France
Contact: Patrick Le Pogamp, MD/PhD         Patrick.LePogamp@chu-rennes.fr    
CHU Rouen Recruiting
Rouen, France
Contact: Michel GODIN, MD/PhD         michel.godin@chu-rouen.fr    
Hopitaux Universitaires de Strasbourg Recruiting
Strasbourg, France
Contact: Bruno MOULIN, MD/PhD         bruno.moulin@nephro.u-strasbg.fr    
CHU Rangueil - Toulouse Recruiting
Toulouse, France
Contact: Dominique Durand, MD/PhD         durand.d@chu-toulouse.fr    
CHU Tours Recruiting
Tours, France
Contact: Yvon Le Branchu, MD/PhD         lebranchu@med.univ-tours.fr    
Sponsors and Collaborators
University Hospital, Brest
Novartis
Roche Pharma AG
Genzyme
Ministry of Health, France
Investigators
Principal Investigator: Yannick LE MEUR, MD/PhD CHU de Brest
  More Information

No publications provided

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01028092     History of Changes
Other Study ID Numbers: EVEROLD, RB 09.074
Study First Received: December 8, 2009
Last Updated: May 16, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Mycophenolic Acid
Immunosuppressive Agents
Mycophenolate mofetil
Everolimus
Sirolimus
Interleukin-2
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
 Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Antibiotics, Antineoplastic
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 17, 2013