Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200551
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2005-09-12
Brief Title:
A Study of Mycophenolate Mofetil and Cyclosporin Without Concomitant Corticosteroids After a First Renal Transplant
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The trial is planned as a multicentric randomized prospective open study in accordance with a 11 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 andor calcineurin inhibitors ie 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 patients life expectancy as a result of the reduction in cardiovascular complications Cardiovascular complications are the most frequent cause of death after a renal transplant
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None