The purpose of this study is to evaluate the use of a novel method to measure adherence to immunosuppressant medications in predicting rejection episodes in children who had a liver transplant.
During the course of their illness as many as 50% of children who had a liver transplant stop taking their medications. Non-adherence is the most important reason for organ rejection in long term survivors of pediatric liver transplantation. In order to address this important risk-factor effectively, the first step is to evaluate a method that would identify non-adherence in these children. Medication blood levels that are obtained as a part of clinical practice in transplant centers can be used to determine whether the patient is adherent or not. This multi-center observational study tests the ability of an objective measure of adherence to immunosuppressant medications that involves the use of routinely obtained tacrolimus blood levels to predict organ rejection in children who had a liver transplant.
Study Type
OBSERVATIONAL
Enrollment
401
UCLA Medical Center
Los Angeles, California, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rejection episodes
Adherence measured through the use of the standard deviation of a series of tacrolimus blood levels obtained during the course of follow-up is the primary predictor.
Time frame: Quarterly for 2 years unless a rejection occurs within this time frame.
Retransplantation or death
Time frame: 2 years
Liver function tests
Time frame: Quarterly for 2 years unless a rejection occurs within this time frame.
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Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States