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

This study has been completed.

First Received on December 8, 2006. Last Updated on December 12, 2006 History of Changes

Sponsor:	University Hospital Freiburg
Information provided by:	University Hospital Freiburg
ClinicalTrials.gov Identifier:	NCT00409656

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 II

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 February 09, 2012