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

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ClinicalTrials.gov Identifier: NCT00409656
Recruitment Status : Completed
First Posted : December 11, 2006
Last Update Posted : December 13, 2006
Sponsor:
Information provided by:
University Hospital Freiburg

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 Type : Interventional  (Clinical Trial)
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 : December 2003
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Basiliximab
U.S. FDA Resources




Primary Outcome Measures :
  1. Graft rejection

Secondary Outcome Measures :
  1. Clear graft survival


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • high risk keratoplasty

Exclusion Criteria:

  • normal risk keratoplasty

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409656


Sponsors and Collaborators
University Hospital Freiburg
Investigators
Study Director: Thomas Reinhard, MD, Prof. University Eye Hospital, Freiburg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00409656     History of Changes
Other Study ID Numbers: FR-2003-12-2005-12
First Posted: December 11, 2006    Key Record Dates
Last Update Posted: December 13, 2006
Last Verified: December 2006

Additional relevant MeSH terms:
Basiliximab
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs