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Completed

NCT Number: NCT00298883

Desensitization of Renal Transplant Candidates

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

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Kidney Transplantation Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myfortic

Drug

Myfortic 360mg PO BID for six weeks

Primary outcomes

  1. decrease in antibody reactivity

    Time frame: six weeks

Secondary outcomes

  1. CBC and CMP values </> 2 times normal

    Time frame: six weeks

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Novartis

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 3, 2006
Registry last updated
Jul 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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