Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation

This study has been completed.
Sponsor:
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT00461825
First received: March 30, 2007
Last updated: April 17, 2007
Last verified: April 2007
  Purpose

We have previously defined factors that predict the long term success of maintenance CsA monotherapy (CsAm) after kidney transplantation : donor age < 40 years, serum creatinine level at the initiation of CsAm £ 125 µmol/L, no rejection episode before CsAm initiation. We have also shown that the 8-year graft survival in 329 selected patients enrolled in maintenance CsA-m was 84 % (Hurault de Ligny et al, Transplantation, 2000 ; 69 : 1327-1332). These results were obtained with an old formulation of cyclosporin, azathioprine, steroid withdrawal over the first year and induction antibody. This prospective randomized multicentre study was designed to clarify whether maintenance Neoral + MMF or Neoral + AZA is better than a CsAm and wether Neoral + MMF is better than Neoral + AZA in low immunological risk cadaveric kidney transplant recipients.


Condition Intervention Phase
Kidney Transplantation
Drug: Cyclosporin A: C0: 75–125ng/ml-dose adapted in the 3 groups
Drug: Group A: CsA + Azathioprine(1 to 2 mg/kg/day)
Drug: Group B: CsA + CellCept(500 mg x 2/day)
Drug: Group C: CsAm
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: Efficacy and Safety of Maintenance Neoral Compared to Bitherapy Neoral-Imurel or Neoral-CellCept in Renal Transplantation

Resource links provided by NLM:


Further study details as provided by Poitiers University Hospital:

Primary Outcome Measures:
  • to compare maintenance CsAm with dual therapy groups and within dual therapy MMF with AZA for :
  • The incidence and the delay of occurrence of graft dysfunction episode defined as ³ 20 % increase in serum creatinine level (mean of three results obtained in the same laboratory) and requiring a graft biopsy.
  • Causes of graft dysfunction episodes diagnosed by graft biopsy.
  • The incidence of serious infections (HVZ, EBV, HPV genital infection, febrile UTI, pneumonitis...)

Secondary Outcome Measures:
  • To compare the three treatment groups for the following parameters :
  • Incidence of therapeutic failure defined by biopsy proven acute rejection episode or CsA renal toxicity
  • Graft function evaluated by serum creatinine level and calculated creatinine clearance (CG formula)
  • Adverse events
  • Patient and graft survival

Estimated Enrollment: 207
Study Start Date: July 1998
Study Completion Date: February 2007
Detailed Description:

Between july 1998 and january 2004 selected patients were randomly assigned equally within each centre to receive CsAm or bitherapy with equally CsA + MMF or CsA + AZA.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Inclusion criteria:

    • Primary cadaveric renal transplant with induction therapy, delayed Neoral, MMF and prednisone
    • Steroid withdrawal >= 3 months before enrolment
    • Bitherapy Neoral + CellCept
    • Follow up time since transplantation : 11-24 months
    • Recipient age >= 25 years
    • Donor age <= 45 years
    • Serum creatinine level <= 125 µmol/L and/or calculated creatinine clearance >= 50 ml/mn (CG formula)
    • No or only one steroid-sensitive acute rejection episode during the first year post-transplantation
    • PRA <= 25 %
    • Written informed consent
  • Exclusion Criteria:

    • Living donor transplantation
    • Recipient receiving tacrolimus
    • Azathioprine intolerance
    • Thrombopenia < 100 000/mm³
    • Neutropenia < 1500/mm³
    • Hemoglobinemia <= 8g/dl
    • On going infection
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00461825

Locations
France
Caen university Hospital
Caen, France, 14033
Dupuytren University Hospital
Limoges, France, 87042
Poitiers University hospital
Poitiers, France, 86021
Reims University Hospital
Reims, France, 51092
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
Poitiers University Hospital
Investigators
Principal Investigator: TOUCHARD Guy, MD,Professor Poitiers University Hospital, POITIERS, 86021, FRANCE
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00461825     History of Changes
Other Study ID Numbers: Afssaps-980654
Study First Received: March 30, 2007
Last Updated: April 17, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Poitiers University Hospital:
Immunosuppression
Kidney transplantation
multicenter study

Additional relevant MeSH terms:
Azathioprine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 16, 2014