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Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation

NCT00461825 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2007-04-18

No results posted yet for this study

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.

Conditions

  • Kidney Transplantation

Interventions

DRUG

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

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Principal Investigators

  • TOUCHARD Guy, MD,Professor · Poitiers University Hospital, POITIERS, 86021, FRANCE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-07-31
Completion
2007-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00461825 on ClinicalTrials.gov