End Stage Renal Disease, Kidney Transplantation
Conditions
Keywords
Renal, Transplant, PRA
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.
Interventions
DRUGMyfortic
Myfortic 360mg PO BID for six weeks
Sponsors
Novartis
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Any subjects not meeting the Inclusion Criteria * Subjects unable to attend weekly clinic visits for six weeks * Inability to tolerate Myfortic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| decrease in antibody reactivity | six weeks |
Secondary
| Measure | Time frame |
|---|---|
| CBC and CMP values </> 2 times normal | six weeks |
Countries
United States
Outcome results
None listed