Desensitization of Renal Transplant Candidates

July 24, 2012 updated by: University of Florida
Trial of the use of Myfortic to reduce anti-HLA alloantibody in patients waiting for renal transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
decrease in antibody reactivity
Time Frame: six weeks
six weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
CBC and CMP values </> 2 times normal
Time Frame: six weeks
six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

Novartis

Investigators

  • Principal Investigator: Shiro Fujita, MD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

March 1, 2006

First Submitted That Met QC Criteria

March 1, 2006

First Posted (Estimate)

March 3, 2006

Study Record Updates

Last Update Posted (Estimate)

July 25, 2012

Last Update Submitted That Met QC Criteria

July 24, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 584-2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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