Desensitization of Renal Transplant Candidates

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT00298883
• Collaborator: Novartis (Industry)
• Enrollment: 9
• Location: 1
• Arm: 1
• Duration (Months): 34
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Desensitization of Renal Transplant Candidates
• Study Start Date: Feb 1, 2006
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. decrease in antibody reactivity [six weeks]

Secondary Outcome Measures

1. CBC and CMP values </> 2 times normal [six weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32610

Sponsors and Collaborators

• University of Florida
• Novartis

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT00298883
• Other Study ID Numbers: 584-2004
• First Posted: Mar 3, 2006
• Last Update Posted: Jul 25, 2012
• Last Verified: Jul 1, 2012

• Keywords provided by University of Florida: Renal; Transplant; PRA
• Additional relevant MeSH terms: Kidney Failure, Chronic; Mycophenolic Acid

Study Results

No Results Posted as of Jul 25, 2012