Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261547
Status:
WITHDRAWN
Last Update Posted:
2023-10-23
First Post:
2005-12-01
Brief Title:
Rituximab Treatment to Block HLA Antibodies in Renal Transplant Recipients
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Pilot Study of Rituximab Treatment to Inhibit HLA Antibodies in Renal Allograft Recipients
Status:
WITHDRAWN
Status Verified Date:
2023-10
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 purpose of this study is to determine if administration of rituximab blocks the development of donor specific antibodies DSA in transplant recipients who have developed renal dysfunction and DSA after renal transplant It is hoped that by blocking DSA production renal function will stabilize or improve
Detailed Description:
A long established risk factor for late renal allograft loss is the development of DSA Recent studies from our group and others have shown that these antibodies are probably responsible for chronic rejection by attacking the vascular endothelium and fixing complement detected as C4d in renal biopsies Studies in humans and monkeys have shown that circulating antibody and complement deposition precede the development of chronic graft injury Interruption of antibody production is a potential beneficial strategy to prevent late graft loss from this mechanism
Therapeutic regimens that have been used in an attempt to deplete HLA or ABO antibodies include plasmapheresis IVIg tacrolimus and mycophenolate mofetil MMF and anti-CD20 rituximab Of these regimens the most specific is anti-CD20 rituximab rituxan a therapy now FDA approved for B cell proliferative diseases Although initially introduced for the treatment of neoplasm the humoral immunosuppressant effects of rituximab have been shown to have clinical significance Rituximab interferes with both primary and secondary humoral responses by eliminating B-cells prior to antigen exposure thus interfering with differentiation into antibody secreting cells and specific antibody production
Therapeutic regimens that have been used in an attempt to deplete HLA or ABO antibodies include plasmapheresis IVIg tacrolimus and mycophenolate mofetil MMF and anti-CD20 rituximab Of these regimens the most specific is anti-CD20 rituximab rituxan a therapy now FDA approved for B cell proliferative diseases Although initially introduced for the treatment of neoplasm the humoral immunosuppressant effects of rituximab have been shown to have clinical significance Rituximab interferes with both primary and secondary humoral responses by eliminating B-cells prior to antigen exposure thus interfering with differentiation into antibody secreting cells and specific antibody production
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