Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation

April 17, 2007 updated by: Poitiers University Hospital

Efficacy and Safety of Maintenance Neoral Compared to Bitherapy Neoral-Imurel or Neoral-CellCept in Renal Transplantation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

207

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14033
        • Caen University hospital
      • Limoges, France, 87042
        • DUPUYTREN University Hospital
      • Poitiers, France, 86021
        • Poitiers University Hospital
      • Reims, France, 51092
        • Reims University Hospital
      • Rouen, France, 76031
        • Rouen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Measures

Outcome Measure
Adverse events
Patient and graft survival
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Investigators

  • Principal Investigator: TOUCHARD Guy, MD,Professor, Poitiers University Hospital, POITIERS, 86021, FRANCE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1998

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

March 30, 2007

First Submitted That Met QC Criteria

April 17, 2007

First Posted (Estimate)

April 18, 2007

Study Record Updates

Last Update Posted (Estimate)

April 18, 2007

Last Update Submitted That Met QC Criteria

April 17, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Afssaps-980654

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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