Prospective, Randomized Trial of Basiliximab (Simulect) in the Prophylaxis of High-Risk Keratoplasty Patients
Information source: University Hospital Freiburg
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Corneal Transplantation
Intervention: Basiliximab (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University Hospital Freiburg Official(s) and/or principal investigator(s):
Thomas Reinhard, MD, Prof., Study Director, Affiliation: University eye hospital, Freiburg
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.
Clinical Details
Official title: Prospective, Randomized Trial of Basiliximab (Simulect) in the Prophylaxis of High-Risk Keratoplasty Patients
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Graft rejection
Secondary outcome: Clear graft survival
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- high risk keratoplasty
Exclusion Criteria:
- normal risk keratoplasty
Locations and Contacts
Additional Information
Starting date: December 2003
Ending date: December 2005
Last updated: December 12, 2006
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