Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation

Poitiers University Hospital207 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

207

Conditions

Kidney Transplantation

Interventions

Eligibility

Sex: ALLMin age: 25 Years

Medical Language ↔ Plain English

* 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 (5)

Caen university Hospital

Caen, France

Dupuytren University Hospital

Limoges, France

Poitiers University hospital

Poitiers, France

Reims University Hospital

Reims, France

Rouen University Hospital

Rouen, France

Outcomes

Primary Outcomes

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 Outcomes

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