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: September 30, 2013
Last verified: September 2013

June 29, 2010
September 30, 2013
August 2010
June 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01154075 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Adherence as measured by refill rates [ Time Frame: Quarterly for 2 years unless a rejection occurs within this time frame. ] [ 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 ]
Not Provided
Not Provided
 
Medication Adherence in Children Who Had a Liver Transplant
Medication Adherence in Children Who Had a Liver Transplant

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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

Non-Probability Sample

Pediatric patients receiving liver transplantation

Pediatric Recipients of a Liver Transplant
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
401
June 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
1 Year to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01154075
GCO 09-1112, R01 DK080740
Yes
Mount Sinai School of Medicine
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
Principal Investigator: Eyal Shemesh, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP