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Medication Adherence in Children Who Had a Liver Transplant (MALT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Children's Hospital Medical Center, Cincinnati
Children's Hospital of Pittsburgh
Ann & Robert H Lurie Children's Hospital of Chicago
University of California, Los Angeles
The EMMES Corporation
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01154075
First received: June 29, 2010
Last updated: July 3, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition
Pediatric Recipients of a Liver Transplant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medication Adherence in Children Who Had a Liver Transplant

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Rejection episodes [ Time Frame: Quarterly for 2 years unless a rejection occurs within this time frame. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Retransplantation or death [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Liver function tests [ Time Frame: Quarterly for 2 years unless a rejection occurs within this time frame. ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

liver tissue samples (from biopsies performed for clinical, not investigational, reasons)


Enrollment: 401
Study Start Date: August 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric patients receiving liver transplantation

Criteria

Inclusion Criteria:

  • The patient is between > 1 year of age and less than 18 years of age at enrollment
  • Guardian's consent, child assent (in accordance with each institution's IRB policies).
  • The patient is prescribed tacrolimus (either brand or generic formulation).
  • The patient has been seen in the enrolling center's clinic at least once in the last two years.

Exclusion Criteria:

  • The patient received a liver transplant less than 1 year prior to enrollment.
  • The patient has had more than one solid organ transplant (including marrow replacement).
  • The patient has had biopsy-proven rejection within the past six months.
  • The patient has been diagnosed with Hepatitis C.
  • The guardian or child (in a developmentally-appropriate manner) do not understand the study procedures. This will be verified by asking both guardian and child (if 6 years old or older) to repeat the study procedures.
  • The patient is only seen for consultation - most or all of the child's routine care is provided at another center (or in a community clinic).
  • Either the patient or the guardian is actively psychotic or severely disoriented due to any cause, including hepatic encephalopathy (temporary exclusion) or severely mentally retarded as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).
  • The patient is not medically stable or is hospitalized.
  • The treating physician has instructed the participant not to obtain tacrolimus levels for at least one year.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01154075

Locations
United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Mount Sinai School of Medicine
Children's Hospital Medical Center, Cincinnati
Children's Hospital of Pittsburgh
Ann & Robert H Lurie Children's Hospital of Chicago
University of California, Los Angeles
The EMMES Corporation
Investigators
Principal Investigator: Eyal Shemesh, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01154075     History of Changes
Other Study ID Numbers: GCO 09-1112, R01 DK080740
Study First Received: June 29, 2010
Last Updated: July 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Liver transplant
Adherence
Compliance
Tacrolimus

ClinicalTrials.gov processed this record on May 23, 2013