Desensitization of Renal Transplant Candidates

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00298883
First received: March 1, 2006
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
End Stage Renal Disease
Kidney Transplantation
Drug: Myfortic
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Desensitization of Renal Transplant Candidates

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • decrease in antibody reactivity [ Time Frame: six weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CBC and CMP values </> 2 times normal [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: February 2006
Study Completion Date: December 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
This is a single arm, interventional trial.
Drug: Myfortic
Myfortic 360mg PO BID for six weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298883

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Novartis
Investigators
Principal Investigator: Shiro Fujita, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00298883     History of Changes
Other Study ID Numbers: 584-2004
Study First Received: March 1, 2006
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Florida:
Renal
Transplant
PRA

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014