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

StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Publications: details revised at 1 of 1 entry

    Study Identification, Study Status, Referencesv5

  2. Minor

    Trial status: Active, Not Recruiting to Completed

    Study sites: 1 to 5; Primary completion date: Apr 2010

    Study Identification, Study Status, Contacts/Locationsv4

  3. Minor

    Secondary endpoints revised (8)

    Show what changed: Secondary endpoints
    - 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 transpla [...]

    Study Status, Study Description, Outcome Measuresv3

  4. Minor

    Study title shortened, about 21 words

    Show what changed: Study title
    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.

    Study Identification, Study Statusv2

  5. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00200551
Lead Sponsor Nantes University Hospital
Conditions Renal Transplantation
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov