Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation
Status:
Completed
Trial end date:
2007-02-01
Target enrollment:
Participant gender:
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.