Pediatric Recipients of a Liver TransplantMALTNCT01154075
Medication Adherence in Children Who Had a Liver Transplant
An observational study of Pediatric Recipients of a Liver Transplant, run by Icahn School of Medicine at Mount Sinai at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the use of a novel method to measure adherence to immunosuppressant medications in predicting rejection episodes in children who had a liver transplant. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Pediatric Recipients of a Liver Transplant
- How many people
- 401 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2010to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients receiving liver transplantation
Who may be able to join
- The patient is between > 1 year of age and less than 18 years of age at enrollment
- Guardian's consent, child assent (in accordance with each institution's IRB policies).
- The patient is prescribed tacrolimus (either brand or generic formulation).
- The patient has been seen in the enrolling center's clinic at least once in the last two years.
Who cannot join
- The patient received a liver transplant less than 1 year prior to enrollment.
- The patient has had more than one solid organ transplant (including marrow replacement).
- The patient has had biopsy-proven rejection within the past six months.
- The patient has been diagnosed with Hepatitis C.
- The guardian or child (in a developmentally-appropriate manner) do not understand the study procedures. This will be verified by asking both guardian and child (if 6 years old or older) to repeat the study procedures.
- The patient is only seen for consultation - most or all of the child's routine care is provided at another center (or in a community clinic).
Show all 9Show fewer
- Either the patient or the guardian is actively psychotic or severely disoriented due to any cause, including hepatic encephalopathy (temporary exclusion) or severely mentally retarded as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).
- The patient is not medically stable or is hospitalized.
- The treating physician has instructed the participant not to obtain tacrolimus levels for at least one year.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Children's Memorial Hospital
Chicago, Illinois, 60614
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
UCLA Medical Center
Los Angeles, California, 90095
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
The purpose of this study is to evaluate the use of a novel method to measure adherence to immunosuppressant medications in predicting rejection episodes in children who had a liver transplant.
Read the detailed description
During the course of their illness as many as 50% of children who had a liver transplant stop taking their medications. Non-adherence is the most important reason for organ rejection in long term survivors of pediatric liver transplantation. In order to address this important risk-factor effectively, the first step is to evaluate a method that would identify non-adherence in these children. Medication blood levels that are obtained as a part of clinical practice in transplant centers can be used to determine whether the patient is adherent or not. This multi-center observational study tests the ability of an objective measure of adherence to immunosuppressant medications that involves the use of routinely obtained tacrolimus blood levels to predict organ rejection in children who had a liver transplant.
- Keywords
- Liver transplant, Adherence, Compliance, Tacrolimus
- Medical subject headings
- Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
Rejection episodes
Adherence measured through the use of the standard deviation of a series of tacrolimus blood levels obtained during the course of follow-up is the primary predictor.
Measured: Quarterly for 2 years unless a rejection occurs within this time frame.
Secondary outcomes (2)
Retransplantation or death
Measured: 2 years
Liver function tests
Measured: Quarterly for 2 years unless a rejection occurs within this time frame.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Recipients of a Liver TransplantStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, University of Pittsburgh, Ann & Robert H Lurie Children's Hospital of Chicago, University of California, Los Angeles, The Emmes Company, LLC, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Eyal Shemesh, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154075
- Sponsor's protocol ID
- GCO 09-1112
- Other IDs
- R01DK080740
- Acronym
- MALT
- Status last verified
- Dec 2017
- First submitted
- 29 Jun 2010
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shemesh E, Bucuvalas JC, Anand R, Mazariegos GV, Alonso EM, Venick RS, Reyes-Mugica M, Annunziato RA, Shneider BL. The Medication Level Variability Index (MLVI) Predicts Poor Liver Transplant Outcomes: A Prospective Multi-Site Study. Am J Transplant. 2017 Oct;17(10):2668-2678. doi: 10.1111/ajt.14276. Epub 2017 Apr 22.
PubMed 28321975
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Adherence in Children Who Had a Liver Transplant
- ClinicalTrials.gov ID
- NCT01154075
- Acronym / sponsor ID
- MALT / GCO 09-1112
- Keywords
- Liver transplant, Adherence, Compliance, Tacrolimus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, University of Pittsburgh, Ann & Robert H Lurie Children's Hospital of Chicago, University of California, Los Angeles, The Emmes Company, LLC, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the use of a novel method to measure adherence to immunosuppressant medications in predicting rejection episodes in children who had a liver transplant.
Detailed description
During the course of their illness as many as 50% of children who had a liver transplant stop taking their medications. Non-adherence is the most important reason for organ rejection in long term survivors of pediatric liver transplantation. In order to address this important risk-factor effectively, the first step is to evaluate a method that would identify non-adherence in these children. Medication blood levels that are obtained as a part of clinical practice in transplant centers can be used to determine whether the patient is adherent or not. This multi-center observational study tests the ability of an objective measure of adherence to immunosuppressant medications that involves the use of routinely obtained tacrolimus blood levels to predict organ rejection in children who had a liver transplant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients receiving liver transplantation
Key inclusion criteria (4 listed)
- The patient is between > 1 year of age and less than 18 years of age at enrollment
- Guardian's consent, child assent (in accordance with each institution's IRB policies).
- The patient is prescribed tacrolimus (either brand or generic formulation).
- The patient has been seen in the enrolling center's clinic at least once in the last two years.
Key exclusion criteria (9 listed)
- The patient received a liver transplant less than 1 year prior to enrollment.
- The patient has had more than one solid organ transplant (including marrow replacement).
- The patient has had biopsy-proven rejection within the past six months.
- The patient has been diagnosed with Hepatitis C.
- The guardian or child (in a developmentally-appropriate manner) do not understand the study procedures. This will be verified by asking both guardian and child (if 6 years old or older) to repeat the study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rejection episodes
Time frame: Quarterly for 2 years unless a rejection occurs within this time frame.
Adherence measured through the use of the standard deviation of a series of tacrolimus blood levels obtained during the course of follow-up is the primary predictor.
2 secondary outcomes
Retransplantation or death
Time frame: 2 years
Liver function tests
Time frame: Quarterly for 2 years unless a rejection occurs within this time frame.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Results publication: PubMed 28321975Shemesh E, Bucuvalas JC, Anand R, Mazariegos GV, Alonso EM, Venick RS, Reyes-Mugica M, Annunziato RA, Shneider BL. The Medication Level Variability Index (MLVI) Predicts Poor Liver Transplant Outcomes: A Prospective Multi-Site Study. Am J Transplant. 2017 Oct;17(10):2668-2678. doi: 10.1111/ajt.14276. Epub 2017 Apr 22.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eyal Shemesh, MD principal investigator
Icahn School of Medicine at Mount Sinai
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Recipients of a Liver Transplant, run by Icahn School of Medicine at Mount Sinai at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rejection episodes (time frame: Quarterly for 2 years unless a rejection occurs within this time frame.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01154075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.