A Study of Mycophenolate Mofetil and Cyclosporin, Without Concomitant Corticosteroids, After a First Renal Transplant

February 4, 2013 updated by: Nantes University Hospital

A Prospective, Randomized, Open, Multicentric Study Intended to Evaluate the Efficacy and Tolerability of Sequential Treatment Based on Rabbit Anti-T-lymphocyte Serum, of Mycophenolate Mofetil and of Cyclosporin, Without Concomitant Corticosteroids, After a First Cadaveric Renal Transplant

The trial is planned as a multicentric, randomized, prospective, open study in accordance with a 1/1 plan, on parallel groups and 2 arms of treatment. A total of 200 patients with chronic renal insufficiency, included in the French national waiting list of the Establishment Français des Greffes [French Transplants Institution] and receiving a first renal transplant will be included, after signed agreement, in this study. All the patients will receive organs taken from brain-dead subjects. The patients will be given immunosuppressant treatment based on rabbit anti-T lymphocyte serum, CellCeptÒ and NeoralÒ cyclosporin. One group of 100 randomised patients will be given standard corticosteroid therapy as well during the first six months following the transplant. This group will be compared with a second group of 100 randomised patients who will be given a single dose of corticosteroids. The main aim of this study is to evaluate the number of acute rejection episodes in patients given a first renal transplant and subjected to an immunosuppressant protocol not containing corticosteroids. The hypothesis which is proposed is that, in the absence of corticosteroids and/or calcineurin inhibitors (i.e. cyclosporin and tacrolimus), antilymphocyte serum results in a certain state of "tolerance" in respect of the allograft. The second objective concerns the beneficial effect which the absence of corticosteroids may have on short- and long-term postoperative morbidity and mortality. One may in fact assume that the absence of corticosteroids will result in an extension of the transplant patient's life expectancy as a result of the reduction in cardiovascular complications. Cardiovascular complications are the most frequent cause of death after a renal transplant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

Phase

  • Phase 4

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
      • Montpellier, France, 34059
        • Montpellier Universitary Hospital
      • Nantes, France, 44093
        • Nantes University Hospital
      • Nice, France, 06202
        • Nice Universitary Hospital
      • Strasbourg, France, 67091
        • Strasbourg Universitary Hospital
    • Besançon
      • France, Besançon, France, 25030
        • Besançon Universitary 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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient who is a candidate for a first cadaver renal transplantation and included on the national list of the Etablissement Français des Greffes
  • Man or woman aged between 18 and 65 years
  • Women of reproductive age must agree to use a reliable contraceptive method throughout the first year of the study
  • Donor aged between 18 and 65 years
  • Patient who has been given full information about the study and who has given his written informed consent to take part in it.

Exclusion Criteria:

  • Women who are pregnant or breast-feeding
  • Patient with an immunological risk considered high and defined as a percentage of anti-HLA antibodies of ³20% (previous or recent determination of T lymphocytes)
  • Patient with a history of allergy to rabbit proteins
  • Cold ischaemia time of more than 36 hours
  • Patient allergic to macrolide antibiotics, to tacrolimus or to MMF
  • Patient on immunosuppressant treatment before transplantation
  • Patient suffering from a malignant neoplasm or with a history of malignant neoplasia, with the exception of treated baso- or spinocellular cancers
  • Patient waiting for another transplant in addition to the kidney
  • Patient who has already received an organ or tissue graft
  • Leukocyte count <2000/mm3 and/or platelet count <50 000/mm3
  • Patient suffering from focal glomerulonephritis

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 evaluate the number of acute rejection episodes during the first year after transplantation in patients given a first renal transplant and subjected to an immunosuppressant protocol not containing corticosteroids.

Secondary Outcome Measures

Outcome Measure
Clinical tolerance of the treatment with antilymphocyte
Any complication related to the corticosteroid treatment
Graft survival at 1, 2, 3, 4 and 5 years
Patient survival at 1, 2, 3, 4 and 5 years
Incidence of infectious and tumoral complications at 1, 2, 3, 4 and 5 years
Incidence of cardiovascular complications at 1, 2, 3, 4 and 5 years
Incidence of metabolic and lipid disorders at 1, 2, 3, 4 and 5 years
Bone osteodensitometry and folic acid levels before transplantation and at 2 weeks, 3 and 6 month after transplantation; then yearly up to 5 years.

Collaborators and Investigators

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

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Diego CANTAROVICH, MD, Nantes UH

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

January 1, 2001

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

February 5, 2013

Last Update Submitted That Met QC Criteria

February 4, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD/00/6-G

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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