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Sponsors and Collaborators: |
University of Florida Novartis |
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Information provided by: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00298883 |
Trial of the use of Myfortic to reduce anti-HLA alloantibody in patients waiting for renal transplantation.
Condition | Intervention | Phase |
---|---|---|
End Stage Renal Disease Kidney Transplantation |
Drug: Myfortic |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Desensitization of Renal Transplant Candidates |
Estimated Enrollment: | 20 |
Study Start Date: | February 2006 |
Study Completion Date: | December 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Treatment: Experimental
This is a single arm, interventional trial.
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Drug: Myfortic
Myfortic 360mg PO BID for six weeks
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
University of Florida | |
Gainesville, Florida, United States, 32610 |
Principal Investigator: | Shiro Fujita, MD | University of Florida |
Responsible Party: | Univ. of Florida ( Herwig-Ulf Meier-Kriesche ) |
Study ID Numbers: | 584-2004 |
Study First Received: | March 1, 2006 |
Last Updated: | January 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00298883 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Renal Transplant PRA |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Mycophenolic Acid |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |