Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation

Poitiers University Hospital

Status and phase: Completed; Phase 3

Conditions: Kidney Transplantation

Treatments: Drug: Group C: CsAm; Drug: Group B: CsA + CellCept(500 mg x 2/day); Drug: Group A: CsA + Azathioprine(1 to 2 mg/kg/day); Drug: Cyclosporin A: C0: 75-125ng/ml-dose adapted in the 3 groups

Study type: Interventional

Funder types: Other

Identifiers

NCT00461825

Afssaps-980654

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)