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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00409656
First received: December 8, 2006
Last updated: December 12, 2006
Last verified: December 2006
History of Changes
  Purpose

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 Intervention Phase
Corneal Transplantation
 Drug: Basiliximab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective, Randomized Trial of Basiliximab (Simulect) in the Prophylaxis of High-Risk Keratoplasty Patients

Resource links provided by NLM:

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

Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Graft rejection

Secondary Outcome Measures:
  • Clear graft survival

Study Start Date: December 2003
Estimated Study Completion Date: December 2005
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • high risk keratoplasty

Exclusion Criteria:

  • normal risk keratoplasty
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409656

Sponsors and Collaborators
University Hospital Freiburg
Investigators
Study Director: Thomas Reinhard, MD, Prof. University eye hospital, Freiburg
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00409656     History of Changes
Other Study ID Numbers: FR-2003-12-2005-12
Study First Received: December 8, 2006
Last Updated: December 12, 2006
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 22, 2013