Research

Alemtuzumab Use in Intestinal Transplant Patients

Pharmacodynamics, Pharmacogenomics and Preliminary Safety and Efficacy of Alemtuzumab Induction and Tacrolimus in Pediatric Intestinal Transplantation
 

Protocol Description

This research study is taking a look at a new regimen of medicines used in intestine transplantation to see how they work to prevent rejection. Traditional combinations of tacrolimus, steroids and thymoglobulin can cause suppression of the function of lymphocytes, delayed growth and development of bones. Chronic rejection, an additional effect of this combination, may occur, causing further complications. In this study, through the use of alemtuzumab in place of thymoglobulin, researchers hope to understand its long-term effects on blood cells and its ability to lower the rate of rejection with possible elimination of the use of steroids.

Eligibility Criteria

Eligible candidates will include males and females, under 25 years of age, who are about to receive an intestinal transplant and have not been diagnosed with cancer or an infectious disease such as hepatitis.
Boys: 25 years and younger
Girls: 25 years and younger

Requirements
Participants will undergo various routine procedures for transplant patients, while receiving alemtuzumab throughout the study duration.
Visits: Multiple, as with conventional post-transplant care
Duration: 1 year

Status: No enrollment. Currently in follow-up phase.

Source of Support
Pediatric Transplantation Department, Children’s Hospital of Pittsburgh of UPMC

Primary Investigator(s)

Rakesh Sindhi, MD

Contact Information

For more information, please contact:
Katie Hindes Kalata, BS, MPH
412-692-8472
or
Kym Smith, BS
412-692-5297

Last Update
October 17, 2012
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Last Update
October 17, 2012
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