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
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Transplant||Behavioral: Telemetric Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||148 participants|
|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.|
|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|
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.
- 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.
- The Standard Deviation of A Series Of Tacrolimus Levels (MLVI) [ Time Frame: 2 Years ]MLVI = Standard Deviation Of Tacrolimus Blood Levels
- Incidence of Locally Determined Biopsy Proven Rejection [ Time Frame: 2 Years ]
- Rate Of Locally Determined Biopsy Proven Rejection [ Time Frame: 2 Years ]
- Rate of Centrally Determined Biopsy Proven Rejection [ Time Frame: 2 Years ]
- Time to Rejection From Enrollment [ Time Frame: 2 Years ]
- Occurrence of Death [ Time Frame: 2 Years ]Number of deaths
- Occurrence of Re-Listing For Transplantation [ Time Frame: 2 Years ]Number of participants listing for retransplantation
- Mean ALT [ Time Frame: 2 Years ]Mean number of achieving above threshold ALT > 150 Alanine Aminotransferase (ALT)
- 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)
- Mean gGT [ Time Frame: 2 Years ]Mean number of achieving above threshold GGT > 150 Gamma Glutamyl Transferase (gGT)
- 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)
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.
|Ages Eligible for Study:||12 Years to 19 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
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
|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|
|The Hospital For Sick Children Toronto|
|Toronto, Ontario, Canada, M5G1X8|
|Principal Investigator:||Eyal Shemesh, MD||Icahn School of Medicine at Mount Sinai|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Eyal Shemesh, Professor, Icahn School of Medicine at Mount Sinai|
|Other Study ID Numbers:||
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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|