Trial | NCT00461825  Report issue

Title

Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation
Efficacy and Safety of Maintenance Neoral Compared to Bitherapy Neoral-Imurel or Neoral-CellCept in Renal Transplantation

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cyclosporine mycophenolate azathioprine ...

  • Study Participants

    207
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.
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.
Study Started
Jul 31
1998
Study Completion
Feb 28
2007
Last Update
Apr 18
2007
Estimate

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

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
No Results Posted