A Study of Mycophenolate Mofetil and Cyclosporin, Without Concomitant Corticosteroids, After a First Renal Transplant
Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
Summary
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.