NCT00461825

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 207 (planned)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
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

Timeline

• Start date: 1998-07-01
• Completion: 2007-02-01
• First posted: 2007-04-18
• Last updated: 2007-04-18

Locations

5 sites across 1 country: France