NCT01154075|CompletedDMC
Medication Adherence in Children Who Had a Liver Transplant
MALT
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MALT
Sponsor study identifier
Secondary identifiers
NIH
observational
401
1 country
5
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2015
Actual (reported)Study Completion
June 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 29, 2010
Actual (reported)June 30, 2010
Actual (reported)August 2010
Date type not reportedThis date has not been verified as actual or estimated.
June 2015
Actual (reported)June 2015
Actual (reported)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.
Quarterly for 2 years unless a rejection occurs within this time frame.
Retransplantation or death
2 years
Liver function tests
Quarterly for 2 years unless a rejection occurs within this time frame.
Pediatric patients receiving liver transplantation
UCLA Medical Center
Los Angeles, California, 90095, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Shemesh E, Bucuvalas JC, Anand R, Mazariegos GV, Alonso EM, Venick RS, Reyes-Mugica M, Annunziato RA, Shneider BL. The Medication Level Variability Index (MLVI) Predicts Poor Liver Transplant Outcomes: A Prospective Multi-Site Study. Am J Transplant. 2017 Oct;17(10):2668-2678. doi: 10.1111/ajt.14276. Epub 2017 Apr 22.
liver tissue samples (from biopsies performed for clinical, not investigational, reasons)
Eyal Shemesh, MD
Icahn School of Medicine at Mount Sinai
401 participants (actual enrollment reported by the registry).
First Submitted
June 29, 2010
First Posted
June 30, 2010
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
June 2015
Actual (reported)Study Completion
June 2015
Actual (reported)Last Updated
December 26, 2017
Record last verified: 2017-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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