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Trial record 1 of 1 for:    IMALT
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Improving Medication Adherence in Adolescents Who Had a Liver Transplant (iMALT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03691220
Recruitment Status : Active, not recruiting
First Posted : October 1, 2018
Last Update Posted : December 19, 2022
Sponsor:
Collaborators:
University of California, Los Angeles
Ann & Robert H Lurie Children's Hospital of Chicago
Baylor College of Medicine
University of Pittsburgh
University of California, San Francisco
Children's Hospital of Michigan
Children's Hospital of Philadelphia
Emory-Children's Center
The Hospital for Sick Children
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Columbia University
Seattle Children's Hospital
University of Miami
Children's Hospital Los Angeles
Information provided by (Responsible Party):
Eyal Shemesh, Icahn School of Medicine at Mount Sinai

Study Description
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Brief Summary:
The study's aim is to test a tailored telemetric intervention to reduce rejection incidence by improving medication adherence in a group of adolescent liver transplant recipients identified as nonadherent by a marker (the Medication Level Variability Index, MLVI).

Condition or disease Intervention/treatment Phase
Transplant Behavioral: Telemetric Intervention Not Applicable

Detailed Description:
This is a prospective, multi-center, randomized controlled trial. The study will be conducted in transplant centers in the United States and Canada. Estimated final sample size of 140 after attrition. Pediatric adolescent and young adult (age at enrollment ≥12 and < 20) transplant recipients will be eligible for participation in the study. Eligible participants will be randomly assigned to intervention or control group. An interim analysis to evaluate efficacy will be performed. Missing data will not be imputed for secondary analyses.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study participants will be randomized to receive the telemetric intervention or standard of care.
Masking: Single (Outcomes Assessor)
Masking Description: Study pathologists will perform masked reading of for-cause biopsy slides.
Primary Purpose: Treatment
Official Title: Improving Medication Adherence in Adolescents Who Had a Liver Transplant
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Telemetric Intervention Arm
Adolescent with MLVI>2 to receive the telemetric intervention.
 Behavioral: Telemetric Intervention
Calls, scripted by a manual; the frequency of the calls varies with patient's MLVI status and preferences.
No Intervention: Standard of Care Arm
Adolescent with MLVI>2 to receive standard of care.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Rejection [ Time Frame: 2 Years ]
    The incidence of biopsy-proven acute cellular rejection (number of patients experiencing at least one episode of rejection) at any time during the 2 years of follow up.Biopsy-confirmed late acute rejection, as determined by the majority of 3 masked readings of liver biopsy images by 3 pathologists that are not from the clinical site at which the patient is treated. Patients with incomplete follow-up (for example due to death, re-transplant, listing for re-transplantation), will be assumed to have experienced a rejection for the purpose of the primary analysis.


Secondary Outcome Measures :
  1. The Standard Deviation of A Series Of Tacrolimus Levels (MLVI) [ Time Frame: 2 Years ]
    MLVI = Standard Deviation Of Tacrolimus Blood Levels

  2. Incidence of Locally Determined Biopsy Proven Rejection [ Time Frame: 2 Years ]
  3. Rate Of Locally Determined Biopsy Proven Rejection [ Time Frame: 2 Years ]
  4. Rate of Centrally Determined Biopsy Proven Rejection [ Time Frame: 2 Years ]
  5. Time to Rejection From Enrollment [ Time Frame: 2 Years ]
  6. Occurrence of Death [ Time Frame: 2 Years ]
    Number of deaths

  7. Occurrence of Re-Listing For Transplantation [ Time Frame: 2 Years ]
    Number of participants listing for retransplantation

  8. Mean ALT [ Time Frame: 2 Years ]
    Mean number of achieving above threshold ALT > 150 Alanine Aminotransferase (ALT)

  9. Mean maximal ALT [ Time Frame: 2 Years ]
    mean/maximal and ALT (defined as in MALT as the mean of all levels recorded during the study period and the maximal level recorded during the study period)

  10. Mean gGT [ Time Frame: 2 Years ]
    Mean number of achieving above threshold GGT > 150 Gamma Glutamyl Transferase (gGT)

  11. Mean maximal gGT [ Time Frame: 2 Years ]
    mean/maximal gGT (defined as in MALT as the mean of all levels recorded during the study period and the maximal level recorded during the study period)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient is ≥ 12 and < 20 years of age at enrollment.
  • ≥2.5 years after last liver transplantation.
  • Guardian's consent, adolescent assent at enrollment.
  • The patient is prescribed tacrolimus.
  • The patient's MLVI (SD of tacrolimus) was > 2 when calculated by the site for a period of 2 years prior to the review date

Exclusion Criteria:

  • The patient has had transplant of an organ other than liver.
  • The patient is currently listed for any organ transplantation.
  • The patient is expected to transition to another service (e.g., adult clinic, another
  • hospital) during the two years of the study.
  • Pregnant patients.
  • A temporary exclusion: the patient is not medically stable or was hospitalized for >48 consecutive hours in the past three months.
  • Site PI, study PI, or Medical Monitor determines that the patient should not be a candidate for the intervention due to factors that are not covered in the above criteria.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691220


Locations
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United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Mattel Children's Hospital UCLA
Los Angeles, California, United States, 90095
Benioff Children's Hospital UCSF
San Francisco, California, United States, 94107
United States, Florida
Miami Transplant Institute
Miami, Florida, United States, 33136
United States, Georgia
Children's Healthcare of Atlanta/Emory
Atlanta, Georgia, United States, 30322
United States, Illinois
Lurie Children's Hospital
Chicago, Illinois, United States, 60611
United States, Michigan
C.S.Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Canada, Ontario
The Hospital For Sick Children Toronto
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
University of California, Los Angeles
Ann & Robert H Lurie Children's Hospital of Chicago
Baylor College of Medicine
University of Pittsburgh
University of California, San Francisco
Children's Hospital of Michigan
Children's Hospital of Philadelphia
Emory-Children's Center
The Hospital for Sick Children
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Columbia University
Seattle Children's Hospital
University of Miami
Children's Hospital Los Angeles
Investigators
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Principal Investigator: Eyal Shemesh, MD Icahn School of Medicine at Mount Sinai
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eyal Shemesh, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03691220    
Other Study ID Numbers: GCO 18-0061
U01DK119200 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: December 19, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eyal Shemesh, Icahn School of Medicine at Mount Sinai:
Intervention
Adherence