Desensitization of Renal Transplant Candidates
Trial of the use of Myfortic to reduce anti-HLA alloantibody in patients waiting for renal transplantation.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Desensitization of Renal Transplant Candidates|
- decrease in antibody reactivity [ Time Frame: six weeks ] [ Designated as safety issue: No ]
- CBC and CMP values </> 2 times normal [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2006|
|Study Completion Date:||December 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
This is a single arm, interventional trial.
Myfortic 360mg PO BID for six weeks
Pre-formed HLA antibodies prevent renal transplantation because of the risk of hyperacute rejection. We propose a prospective study evaluating the efficacy of Enteric Coated Mycophenolate Sodium (Myfortic) in decreasing the titers of anti-HLA alloantibodies in patients awaiting kidney transplantation. Myfortic is an immunosuppressant that inhibits the proliferation of B and T cells by blocking the enzyme inosine monophosphate dehydrogenase. We will attempt to determine whether a 6-week course of Myfortic adequately decreases the antibody reactivity to a level compatible with transplantation.
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Shiro Fujita, MD||University of Florida|