Improving Medication Adherence in Adolescents Who Had a Liver Transplant

Transplant Clinical Trial

— iMALT  

Official title:

Improving Medication Adherence in Adolescents Who Had a Liver Transplant

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03691220
• Other study ID #: GCO 18-0061
• Secondary ID: U01DK119200
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 14, 2018
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 148
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Transplant

Intervention

Behavioral:
• Telemetric Intervention
Calls, scripted by a manual; the frequency of the calls varies with patient's MLVI status and preferences.

Locations

Country	Name	City	State
Canada	The Hospital For Sick Children Toronto	Toronto	Ontario
United States	C.S.Mott Children's Hospital	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta/Emory	Atlanta	Georgia
United States	Lurie Children's Hospital	Chicago	Illinois
United States	Texas Children's Hospital	Houston	Texas
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Mattel Children's Hospital UCLA	Los Angeles	California
United States	Miami Transplant Institute	Miami	Florida
United States	Columbia University Medical Center	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Benioff Children's Hospital UCSF	San Francisco	California

Sponsors (15)

Lead Sponsor

Collaborator

Icahn School of Medicine at Mount Sinai

Ann & Robert H Lurie Children's Hospital of Chicago, Baylor College of Medicine, Children's Hospital Los Angeles, Children's Hospital of Michigan, Children's Hospital of Philadelphia, Columbia University, Emory-Children's Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Seattle Children's Hospital, The Hospital for Sick Children, University of California, Los Angeles, University of California, San Francisco, University of Miami, University of Pittsburgh

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Rejection	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.	2 Years
Secondary	The Standard Deviation of A Series Of Tacrolimus Levels (MLVI)	MLVI = Standard Deviation Of Tacrolimus Blood Levels	2 Years
Secondary	Incidence of Locally Determined Biopsy Proven Rejection		2 Years
Secondary	Rate Of Locally Determined Biopsy Proven Rejection		2 Years
Secondary	Rate of Centrally Determined Biopsy Proven Rejection		2 Years
Secondary	Time to Rejection From Enrollment		2 Years
Secondary	Occurrence of Death	Number of deaths	2 Years
Secondary	Occurrence of Re-Listing For Transplantation	Number of participants listing for retransplantation	2 Years
Secondary	Mean ALT	Mean number of achieving above threshold ALT > 150 Alanine Aminotransferase (ALT)	2 Years
Secondary	Mean maximal ALT	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)	2 Years
Secondary	Mean gGT	Mean number of achieving above threshold GGT > 150 Gamma Glutamyl Transferase (gGT)	2 Years
Secondary	Mean maximal gGT	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)	2 Years

External Links

•   Official Website of The iMALT Study