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Desensitization of Renal Transplant Candidates

Primary Purpose

End Stage Renal Disease, Kidney Transplantation

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Myfortic

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Renal, Transplant, PRA

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

This is a single arm, interventional trial.

Outcomes

Primary Outcome Measures

decrease in antibody reactivity

Secondary Outcome Measures

CBC and CMP values </> 2 times normal

Full Information

NCT ID

NCT00298883

First Posted

March 1, 2006

Last Updated

July 24, 2012

Sponsor

University of Florida

Collaborators

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00298883

Brief Title

Desensitization of Renal Transplant Candidates

Official Title

Desensitization of Renal Transplant Candidates

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

February 2006 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

Novartis

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease, Kidney Transplantation

Keywords

Renal, Transplant, PRA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

This is a single arm, interventional trial.

Intervention Type

Drug

Intervention Name(s)

Myfortic

Intervention Description

Myfortic 360mg PO BID for six weeks

Primary Outcome Measure Information:

Title

decrease in antibody reactivity

Time Frame

six weeks

Secondary Outcome Measure Information:

Title

CBC and CMP values </> 2 times normal

Time Frame

six weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shiro Fujita, MD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Desensitization of Renal Transplant Candidates

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