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Improving Medication Adherence in Adolescents Who Had a Liver Transplant (iMALT)

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ClinicalTrials.gov Identifier: NCT03691220
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : April 22, 2021
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
Information provided by (Responsible Party):
Eyal Shemesh, Icahn School of Medicine at Mount Sinai

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 11 transplant centers in the United States and Canada. Estimated final sample size of 140. Pediatric adolescent and young adult (age at enrollment ≥12 and < 18) 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 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 : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


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.



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)



Information from the National Library of Medicine

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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.

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


Contacts
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Contact: Kinga Picerno, M.S.Ed. 212-241-2842 Kinga.Picerno@mssm.edu
Contact: Rachel Annunziato, Ph.D. 212-659-8776 Rachel.Annunziato@mssm.edu

Locations
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United States, California
Mattel Children's Hospital UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Susan Feist, RN    310-825-4349    SFeist@Mednet.ucla.edu   
Principal Investigator: Robert S Venick, MD         
Benioff Children's Hospital UCSF Recruiting
San Francisco, California, United States, 94107
Contact: Melissa Zerofsky    415-502-6346    Melissa.Zerofsky@ucsf.edu   
Principal Investigator: Emily Perito, MD         
United States, Florida
Miami Transplant Institute Recruiting
Miami, Florida, United States, 33136
Principal Investigator: Tamir Miloh, MD         
United States, Georgia
Children's Healthcare of Atlanta/Emory Recruiting
Atlanta, Georgia, United States, 30322
Contact: Rebecca Cleeton, MPH, CCRP    404-727-5383    rcleeto@emory.edu   
Principal Investigator: Rene Romero, MD         
United States, Illinois
Lurie Children's Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Katie Neighbors, MPH    312-227-4557    KNeighbors@luriechildrens.org   
Principal Investigator: Estella Alonso, MD         
United States, Michigan
C.S.Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Sally J Eder, BA    734-615-4271    Saleder@med.umich.edu   
Principal Investigator: Emily M Fredericks, PHD         
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Kinga Picerno, M.S. Ed.    212-241-2842    Kinga.Picerno@mssm.edu   
Contact: Rachel Annunziato, Ph.D    212-659-8776    Rachel.Annunziato@mssm.edu   
Principal Investigator: Eyal Shemesh, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Grace Bayona    212-305-3839      
Principal Investigator: Steven J Lobritto, M.D.         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Elizabeth Rand, MD    215-590-7801    Rand@email.chop.edu   
Principal Investigator: Elizabeth Rand, MD         
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Alexis Rzempoluch    412-692-5201    alexis.rzempoluch@chp.edu   
Principal Investigator: George Mazariegos, MD         
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Julie Economides    832-824-0411    jmeconom@texaschildrens.org   
Principal Investigator: Tamir Miloh, MD         
United States, Washington
Seattle Children's Hospital Withdrawn
Seattle, Washington, United States, 98105
Canada, Ontario
The Hospital For Sick Children Toronto Recruiting
Toronto, Ontario, Canada, M5G1X8
Contact: Blossom Dharmaraj    416-813-7654    blossom.dharmaraj@sickkids.ca   
Principal Investigator: Vicky Ng, MD         
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
Investigators
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Principal Investigator: Eyal Shemesh, MD Icahn School of Medicine at Mount Sinai
Additional Information:
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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: April 22, 2021
Last Verified: April 2021
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