None listed
Conditions
Brief summary
The aim of this study was to compare the incidence of acute rejection in de novo low risk renal transplant patients after an early cyclosporin or mycophenolate mofetil withdrawal (3 months post graft) from an initial triple drug regimen (cyclosporin + mycophenolate + prednisone). The primary outcome was the incidence of biopsy proven acute rejection (BPAR) episodes at 12 months post graft. We tested the hypothesis of a unilateral equivalence of an incidence of 10% BPAR in the cyclosporin group. With a non inferiority limit of 15% the number of patients to include was 98. To take into account a 10% rate of non assessable patients for the statistical analysis, 108 patients were enrolled (54 in each group).
Interventions
mycophenolate mofetil 2g per day and prednisone 0.15 mg/kg, per day from month 3 to 12 post graft. Both drugs: oral capsules
Sponsors
Protocole Hospitalier de Recherche Clinique (PHRC)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1) First renal transplantation from a deceased donor under a triple drug regimen (cyclosporine + mycophenolate mofetil + prednisone) 2) No acute rejection episode during the first 3 months post graft (time of randomisation) 3) Patients who gave their informed consent and are able to understand the scope of the study
Exclusion criteria
1) Living donor, re-transplantation 2) Panel ractive antibodies > 30% 3) Serum creatinine > 2.5 mg/dl (222 umol/l) 4) Cyclosporine toxicity at the time of randomisation (3 months post graft) 5) Patients with generalized infection at the time of transplantation 6) Women in child-bearing age who do not plan to use efficient contraception 7) Age of donor > 65
Outcome results
None listed