drugset / Trial / NCT00461825

Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation

NCT00461825

Phase 3 Completed 207 enrolled Poitiers University Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
1998-07
Primary completion
Completion
2007-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Azathioprine Small molecule 1 mg/kg
Subject Azathioprine Small molecule 2 mg/kg
Subject Cyclosporine Peptide
Subject Mycophenolate Mofetil Small molecule 500 mg

Indications

No indication recorded.