Clinical trial NCT00461825: Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation
Official title: Efficacy and Safety of Maintenance Neoral Compared to Bitherapy Neoral-Imurel or Neoral-CellCept in Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Keywords: Immunosuppression
Kidney transplantation
multicenter study
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2007-04-18
Enrollment: 207
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: to compare maintenance CsAm with dual therapy groups and within dual therapy MMF with AZA for :
measure: 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.
measure: Causes of graft dysfunction episodes diagnosed by graft biopsy.
measure: The incidence of serious infections (HVZ, EBV, HPV genital infection, febrile UTI, pneumonitis...)
Secondary outcomes:
measure: To compare the three treatment groups for the following parameters :
measure: Incidence of therapeutic failure defined by biopsy proven acute rejection episode or CsA renal toxicity
measure: Graft function evaluated by serum creatinine level and calculated creatinine clearance (CG formula)
measure: Adverse events
measure: Patient and graft survival
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen university Hospital
city: Limoges
country: France
facility: Dupuytren University Hospital
city: Poitiers
country: France
facility: Poitiers University hospital
city: Reims
country: France
facility: Reims University Hospital
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: Poitiers University Hospital, POITIERS, 86021, FRANCE
name: TOUCHARD Guy, MD,Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hurault de Ligny B, Toupance O, Lavaud S, Bauwens M, Peyronnet P, Le Meur Y, Ryckelynck JP, Jolly D, Leroux-Robert C, Touchard G. Factors predicting the long-term success of maintenance cyclosporine monotherapy after kidney transplantation. Transplantation. 2000 Apr 15;69(7):1327-32. doi: 10.1097/00007890-200004150-00019.
citation: Touchard G, Hauet T, Cogny Van Weydevelt F, Hurault de Ligny B, Peyronnet P, Lebranchu Y, Toupance O, N'Doye P, Busson M. Maintenance cyclosporin monotherapy after renal transplantation--clinical predictors of long-term outcome. Nephrol Dial Transplant. 1997 Sep;12(9):1956-60. doi: 10.1093/ndt/12.9.1956.