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

• Sponsor: University Hospital Freiburg (Other)
• Overall Status: Completed
• CT.gov ID: NCT00409656
• Collaborator: (none)
• Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Transplantation	Drug: Basiliximab	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Prospective, Randomized Trial of Basiliximab (Simulect) in the Prophylaxis of High-Risk Keratoplasty Patients
• Study Start Date: Dec 1, 2003
• Study Completion Date: Dec 1, 2005

Outcome Measures

Primary Outcome Measures

1. Graft rejection []

Secondary Outcome Measures

1. Clear graft survival []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• high risk keratoplasty

Exclusion Criteria:

• normal risk keratoplasty

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Hospital Freiburg

Investigators

• Study Director: Thomas Reinhard, MD, Prof., University Eye Hospital, Freiburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00409656
• Other Study ID Numbers: FR-2003-12-2005-12
• First Posted: Dec 11, 2006
• Last Update Posted: Dec 13, 2006
• Last Verified: Dec 1, 2006

• Additional relevant MeSH terms: Basiliximab

Study Results

No Results Posted as of Dec 13, 2006