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

This study has been completed.
Sponsor:
Collaborators:
Novartis
Roche Pharma AG
Genzyme, a Sanofi Company
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01028092
First received: December 8, 2009
Last updated: July 7, 2014
Last verified: July 2014
  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:


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 ]

Enrollment: 327
Study Start Date: March 2009
Study Completion Date: July 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028092

Locations
France
CHU Amiens
Amiens, France
CHU Pellegrin - Bordeaux
Bordeaux, France
CHRU de BREST
Brest, France, 29609
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
Sponsors and Collaborators
University Hospital, Brest
Novartis
Roche Pharma AG
Genzyme, a Sanofi Company
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: July 7, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
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 August 19, 2014