A Study of Mycophenolate Mofetil and Cyclosporin, Without Concomitant Corticosteroids, After a First 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.
Drug: Cyclosporin, mycophenolate mofetil, antilymphocyte serum and corticoids.
Drug: Cyclosporin, mycophenolate mofetil, antilymphocyte serum without corticoids.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official 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|
- 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.
- 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.
|Study Start Date:||January 2001|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
|Besançon Universitary Hospital|
|France, Besançon, France, 25030|
|Montpellier Universitary Hospital|
|Montpellier, France, 34059|
|Nantes University Hospital|
|Nantes, France, 44093|
|Nice Universitary Hospital|
|Nice, France, 06202|
|Strasbourg Universitary Hospital|
|Strasbourg, France, 67091|
|Principal Investigator:||Diego CANTAROVICH, MD||Nantes UH|