Desensitization of Renal Transplant Candidates

End Stage Renal Disease Clinical Trial

Official title:

Desensitization of Renal Transplant Candidates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00298883
• Other study ID #: 584-2004
• Status: Completed
• Phase: Phase 1
• First received: March 1, 2006
• Last updated: July 24, 2012
• Start date: February 2006
• Est. completion date: December 2008

Study information

• Verified date: July 2012
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Kidney Transplantation

Intervention

Drug:
• Myfortic
Myfortic 360mg PO BID for six weeks

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease in antibody reactivity		six weeks
Secondary	CBC and CMP values </> 2 times normal		six weeks