Desensitization of Renal Transplant Candidates

University of Florida

Status and phase: Completed; Phase 1

Conditions: Kidney Transplantation; End Stage Renal Disease

Treatments: Drug: Myfortic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00298883

584-2004

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Treatment

Experimental group

Description:

This is a single arm, interventional trial.

Treatment:

Drug: Myfortic