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Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00461825
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : April 18, 2007
Information provided by:
Poitiers University Hospital

Brief Summary:
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 or disease Intervention/treatment 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

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Maintenance Neoral Compared to Bitherapy Neoral-Imurel or Neoral-CellCept in Renal Transplantation
Study Start Date : July 1998
Actual Study Completion Date : February 2007

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Primary Outcome Measures :
  1. to compare maintenance CsAm with dual therapy groups and within dual therapy MMF with AZA for :
  2. 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.
  3. Causes of graft dysfunction episodes diagnosed by graft biopsy.
  4. The incidence of serious infections (HVZ, EBV, HPV genital infection, febrile UTI, pneumonitis...)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00461825

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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
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Principal Investigator: TOUCHARD Guy, MD,Professor Poitiers University Hospital, POITIERS, 86021, FRANCE

Layout table for additonal information Identifier: NCT00461825     History of Changes
Other Study ID Numbers: Afssaps-980654
First Posted: April 18, 2007    Key Record Dates
Last Update Posted: April 18, 2007
Last Verified: April 2007

Keywords provided by Poitiers University Hospital:
Kidney transplantation
multicenter study

Additional relevant MeSH terms:
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Mycophenolic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites, Antineoplastic