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Desensitization of Renal Transplant Candidates

NCT ID: NCT00298883

Last Updated: 2012-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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End Stage Renal Disease Kidney Transplantation

Keywords

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Renal Transplant PRA

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

This is a single arm, interventional trial.

Group Type EXPERIMENTAL

Myfortic

Intervention Type DRUG

Myfortic 360mg PO BID for six weeks

Interventions

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Myfortic

Myfortic 360mg PO BID for six weeks

Intervention Type DRUG

Eligibility Criteria

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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.

* Subjects unable to attend weekly clinic visits for six weeks
* Inability to tolerate Myfortic
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shiro Fujita, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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584-2004

Identifier Type: -

Identifier Source: org_study_id