Desensitization of Renal Transplant Candidates
- Registration Number
- NCT00298883
- Lead Sponsor
- University of Florida
- Brief Summary
Trial of the use of Myfortic to reduce anti-HLA alloantibody in patients waiting for renal transplantation.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- Patients on the deceased donor kidney transplant waiting list with panel reactive antibodies >50% and living donor waiting list patients who have a history of a positive crossmatch (donor-specific antibodies) will be eligible for the study.
- Any subjects not meeting the Inclusion Criteria
- Subjects unable to attend weekly clinic visits for six weeks
- Inability to tolerate Myfortic
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Myfortic This is a single arm, interventional trial.
- Primary Outcome Measures
Name Time Method decrease in antibody reactivity six weeks
- Secondary Outcome Measures
Name Time Method CBC and CMP values </> 2 times normal six weeks
Trial Locations
- Locations (1)
University of Florida
🇺🇸Gainesville, Florida, United States