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
Lead SponsorUniversity of Poitiers
StatusCompleted No Results Posted
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.
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