Prospective, Randomized Trial of Basiliximab (Simulect) in the Prophylaxis of High-Risk Keratoplasty Patients

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Freiburg
• Treatments: Antibodies, Monoclonal; Basiliximab

Criteria

Inclusion Criteria:

• high risk keratoplasty

Exclusion Criteria:

• normal risk keratoplasty