Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176059
Status:
COMPLETED
Last Update Posted:
2007-05-10
First Post:
2005-09-09
Brief Title:
Immunoregulatory Effects of Immunoglobulin Induction Therapy in Renal Transplant Recipients
Sponsor:
University of Giessen
Organization:
University of Giessen
Study Overview
Official Title:
Immunoglobulin Induction Therapy in Renal Transplant Recipients on TacrolimusAzathioprine or TacrolimusMMF Effects on Th1 Th2 B Cell-Monokine Responses and Immunoregulatory Autoantibody Levels
Status:
COMPLETED
Status Verified Date:
2007-05
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:
The aim of this randomized prospective study in renal transplant recipients is to investigate immunological short and long-term effects of an IVIG induction therapy
Furthermore clinical endpoints patient and graft survival incidence of acute and chronic rejection infectious diseases and graft function up to three years posttransplant will be analyzed
Furthermore clinical endpoints patient and graft survival incidence of acute and chronic rejection infectious diseases and graft function up to three years posttransplant will be analyzed
Detailed Description:
Intravenous immunoglobulin IVIG preparations are known to be effective in the treatment of various autoimmune and inflammatory disorders due to their immunomodulatory and antiinflammatory properties It has been demonstrated that IVIG is effective in the treatment of acute vascular rejection and steroid resistant cellular rejection Furthermore IVIG has been used to inhibit production of lymphocytotoxic antibodies in highly sensitized patients so that successful cadaveric or living renal transplantation could be performed
The aim of this randomized prospective study in renal transplant recipients is to investigate immunological short and long-term effects of an IVIG induction therapy on Th1 Th2 and B-cellmonocyte responses expression of adhesion molecules costimulatory factors and cytokine receptors and on secretion of immunoregulatory autoantibodies anti-Fab- anti-Fab2G- anti-hinge autoantibodies These autoantibodies have been shown to significantly affect the risk of chronic rejection and graft loss
Furthermore clinical endpoints patient and gaft survival incidence of acute and chronic rejection infectious diseases and graft function up to 3 years will be analyzed
The aim of this randomized prospective study in renal transplant recipients is to investigate immunological short and long-term effects of an IVIG induction therapy on Th1 Th2 and B-cellmonocyte responses expression of adhesion molecules costimulatory factors and cytokine receptors and on secretion of immunoregulatory autoantibodies anti-Fab- anti-Fab2G- anti-hinge autoantibodies These autoantibodies have been shown to significantly affect the risk of chronic rejection and graft loss
Furthermore clinical endpoints patient and gaft survival incidence of acute and chronic rejection infectious diseases and graft function up to 3 years will be analyzed
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