We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Desensitization of Renal Transplant Candidates

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00298883
First Posted: March 3, 2006
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by (Responsible Party):
University of Florida
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00298883     History of Changes
Other Study ID Numbers: 584-2004
First Submitted: March 1, 2006
First Posted: March 3, 2006
Last Update Posted: October 12, 2017
Last Verified: July 2012

Keywords provided by University of Florida:
Renal
Transplant
PRA

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action