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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

Page last updated: August 23, 2015

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