Transplant Clinical Trial
— iMALTOfficial title:
Improving Medication Adherence in Adolescents Who Had a Liver Transplant
Verified date | November 2023 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
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 |
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 |
United States, Canada,
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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