Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409656
Status:
COMPLETED
Last Update Posted:
2006-12-13
First Post:
2006-12-08
Brief Title:
Prospective Randomized Trial of Basiliximab Simulect in the Prophylaxis of High-Risk Keratoplasty Patients
Sponsor:
University Hospital Freiburg
Organization:
University Hospital Freiburg
Study Overview
Official Title:
Prospective Randomized Trial of Basiliximab Simulect in the Prophylaxis of High-Risk Keratoplasty Patients
Status:
COMPLETED
Status Verified Date:
2006-12
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:
Most high risk keratoplasties are currently performed under systemic immunosuppression Immunosuppressants are currently either Cyclosporine A or mycophenolate mofetile administered for around 6 months Due to potentially severe adverse effects new immunosuppressive exerting less side effects would be desirable Basiliximab is a monoclonal chimeric antibody targeted specifically against the Interleukin-2-Rezeptor from activated T-cells This agent is known to specifically inhibit T-cell proliferation upon intravenous application only twice following transplantation Basiliximab has already been demonstrated effective in kidney transplantation
This investigation is a prospective randomized clinical trial on orthotopic high-risk penetrating keratoplasty Basiliximab is evaluated against systemic Cyclosporine A Primary endpoint is graft rejection Secondary endpoint is clear graft survival
This investigation is a prospective randomized clinical trial on orthotopic high-risk penetrating keratoplasty Basiliximab is evaluated against systemic Cyclosporine A Primary endpoint is graft rejection Secondary endpoint is clear graft survival
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