Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261820
Status:
COMPLETED
Last Update Posted:
2006-05-19
First Post:
2005-12-02
Brief Title:
Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Randomized Study To Compare The Safety And Efficacy Of Two Immunosuppressive Regimens In De Novo Renal Allograft RecipientsSirolimus Plus Mycophenolate Mofetil Plus Corticosteroids Following A Rabbit Anti-Human Thymocyte Globulin Induction RATG Vs Tacrolimus Plus Mycophenolate Mofetil Plus Corticosteroids
Status:
COMPLETED
Status Verified Date:
2006-05
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:
Evaluate renal graft function based on the calculated Glomerular Filtration Rate at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction RATG or a standard regimen combining tacrolimus plus mycophenolate mofetil both regimens including corticosteroids in patients undergoing renal allograft transplantation In addition the two treatment groups will be compared with respect to the incidence of acute rejection at 3 6 and 12 months following transplantation and the patient and graft survival at 6 and 12 months after transplantation The safety of sirolimus plus mycophenolate mofetil following an antibody induction ATG will be evaluated beginning in the immediate post-operative period
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