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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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