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NCT00409656 Clinical Trial

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

Corneal Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00409656
Other study ID # FR-2003-12-2005-12
Secondary ID
Status Completed
Phase Phase 2
First received December 8, 2006
Last updated December 12, 2006
Start date December 2003
Est. completion date December 2005

Study information
Verified date December 2006
Source University Hospital Freiburg
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- high risk keratoplasty

Exclusion Criteria:

- normal risk keratoplasty

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Basiliximab

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Freiburg

Outcome
Type Measure Description Time frame Safety issue
Primary Graft rejection
Secondary Clear graft survival
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