Desensitization of Renal Transplant Candidates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00298883
Recruitment Status : Completed
First Posted : March 3, 2006
Last Update Posted : July 25, 2012
Information provided by (Responsible Party):
University of Florida

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

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Kidney Transplantation Drug: Myfortic Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Desensitization of Renal Transplant Candidates
Study Start Date : February 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: Treatment
This is a single arm, interventional trial.
Drug: Myfortic
Myfortic 360mg PO BID for six weeks

Primary Outcome Measures :
  1. decrease in antibody reactivity [ Time Frame: six weeks ]

Secondary Outcome Measures :
  1. CBC and CMP values </> 2 times normal [ Time Frame: six weeks ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00298883

United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Principal Investigator: Shiro Fujita, MD University of Florida

Responsible Party: University of Florida Identifier: NCT00298883     History of Changes
Other Study ID Numbers: 584-2004
First Posted: March 3, 2006    Key Record Dates
Last Update Posted: July 25, 2012
Last Verified: July 2012

Keywords provided by University of Florida:

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action