Kidney Transplantation
Conditions
Keywords
Immunosuppression, Kidney transplantation, multicenter study
Brief 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.
Interventions
DRUGCyclosporin A: C0: 75-125ng/ml-dose adapted in the 3 groups
DRUGGroup A: CsA + Azathioprine(1 to 2 mg/kg/day)
DRUGGroup B: CsA + CellCept(500 mg x 2/day)
DRUGGroup C: CsAm
Sponsors
Poitiers University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to compare maintenance CsAm with dual therapy groups and within dual therapy MMF with AZA for : | — |
| The incidence and the delay of occurrence of graft dysfunction episode defined as ³ 20 % increase in serum creatinine level (mean of three results obtained in the same laboratory) and requiring a graft biopsy. | — |
| Causes of graft dysfunction episodes diagnosed by graft biopsy. | — |
| The incidence of serious infections (HVZ, EBV, HPV genital infection, febrile UTI, pneumonitis...) | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the three treatment groups for the following parameters : | — |
| Patient and graft survival | — |
| Incidence of therapeutic failure defined by biopsy proven acute rejection episode or CsA renal toxicity | — |
| Graft function evaluated by serum creatinine level and calculated creatinine clearance (CG formula) | — |
| Adverse events | — |
Countries
France
Outcome results
None listed