Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation
Information source: Poitiers University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Transplantation
Intervention: 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 (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Poitiers University Hospital Official(s) and/or principal investigator(s): TOUCHARD Guy, MD,Professor, Principal Investigator, Affiliation: Poitiers University Hospital, POITIERS, 86021, FRANCE
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.
Clinical Details
Official title: Efficacy and Safety of Maintenance Neoral Compared to Bitherapy Neoral-Imurel or Neoral-CellCept in Renal Transplantation
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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 outcome: To compare the three treatment groups for the following parameters :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 Patient and graft survival
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
Minimum age: 25 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Caen university Hospital, Caen 14033, France
Dupuytren University Hospital, Limoges 87042, France
Poitiers University hospital, Poitiers 86021, France
Reims University Hospital, Reims 51092, France
Rouen University Hospital, Rouen 76031, France
Additional Information
Related publications: 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. 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.
Starting date: July 1998
Last updated: April 17, 2007
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