Desensitization of Renal Transplant Candidates

University of Florida9 enrolled

Overview

Trial of the use of Myfortic to reduce anti-HLA alloantibody in patients waiting for renal transplantation.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease Kidney Transplantation

Interventions

MyforticDRUG

Myfortic 360mg PO BID for six weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

decrease in antibody reactivity

Time frame: six weeks

Secondary Outcomes

CBC and CMP values </> 2 times normal

Time frame: six weeks

Data from ClinicalTrials.gov

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