Desensitization of Renal Transplant Candidates - Full Text View

Sponsors and Collaborators:	University of Florida Novartis
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00298883

Purpose

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

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Mycophenolic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Desensitization of Renal Transplant Candidates

Further study details as provided by University of Florida:

Primary Outcome Measures:

decrease in antibody reactivity [ Time Frame: six weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CBC and CMP values </> 2 times normal [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	February 2006
Estimated Study Completion Date:	November 2008
Estimated 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.	Drug: Myfortic Myfortic 360mg PO BID for six weeks

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298883

Contacts

Contact: Aaron Eagan, RN	352-846-2571	eaganae@medicine.ufl.edu
Contact: Fujita Shiro, MD		fujita@surgery.ufl.edu

Locations

United States, Florida
University of Florida	Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Shiro Fujita, MD

Sponsors and Collaborators

University of Florida

Novartis

Investigators

Principal Investigator:

Shiro Fujita, MD

University of Florida

More Information

Responsible Party:	Univ. of Florida ( Herwig-Ulf Meier-Kriesche )
Study ID Numbers:	584-2004
Study First Received:	March 1, 2006
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00298883
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Florida:

Renal
Transplant
PRA

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Mycophenolic Acid

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 16, 2009