TransplantNCT02318030
CNTRP POSITIVE Study
An observational study of Transplant and Adaptive Immunity, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Adequate control of immunosuppression is critical in preventing graft failure after solid organ transplantation (SOT) and in avoiding life-threatening viral and malignant complications. Read more about this study
- Who is it for?
- Ages 0 to 25 years
- Conditions the study is for
- Transplant, Adaptive Immunity, EBV
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Apr 2020
- 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 0 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: End stage organ failure, Solid organ transplant
Who may be able to join
- Aim 1
- Listed for or recipient of solid organ transplant
- Planned immunosuppression with oral or enteral tacrolimus post-transplant
- Aim 2
- Solid organ transplant or hematopoietic stem cell transplant recipients <18 years old
- New onset primary EBV during the first year post transplant (either Donor EBV seropositive, recipient EBV seronegative (D+R-) or donor and recipient seronegative (D-R-) at time of transplant) or new onset EBV/PTLD in the first post-transplant year.
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- HSCT patients who develop secondary EBV within the first post transplant year.
- Aim 3
- Single organ, kidney, liver, and heart recipients that are at least 3 months post-transplant and 2 months post hospital discharge
- Intact graft function (not currently listed for re-transplant for any organ type or on dialysis
- Receiving maintenance immunosuppression
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CNTRP Paediatric Outcomes in Transplant: Personalising Immunosuppression to Improve Efficacy (POSITIVE Study)
Adequate control of immunosuppression is critical in preventing graft failure after solid organ transplantation (SOT) and in avoiding life-threatening viral and malignant complications. Prolonging patient and graft survival and delaying re-transplantation as children reach adulthood is critical to optimal use of a scarce resource. This requires tailoring post-transplant management to the unique needs of the child. Immunosuppression management is challenging in infants, children and youth. The interval from birth to young adulthood sees profound changes in physiological processes, body size and immune maturation; infancy and adolescence are the periods of most rapid and dramatic change. Three pivotal factors affect immunosuppression control in the child: 1) age-dependent variation in drug metabolism; 2) developmental changes in immune function with increased childhood susceptibility to infections, including those caused by viruses; and 3) behavioural changes in adolescence and young adulthood linked with poor treatment adherence.
This project will identify the most important factors influencing immunosuppression control across the pediatric age range, from infancy to young adulthood, including age-related changes in drug metabolism, immune function, and susceptibility to viral infections, as well as health care system factors affecting treatment adherence. This is the first comprehensive, multi-organ transplant study to identify age-related biologic and health care systems determinants of variability in immunosuppression control in children and youth. Results will inform personalized age-appropriate strategies to improve immunosuppression control and reduce the unacceptably high graft failure and viral complication rates in this vulnerable population.
The POSITIVE Study brings together researchers across Canada and is one of 6 projects and 3 cores that constitute the Canadian Institute of Health Research (CIHR) funded interdisciplinary research program called the Canadian National Transplant Research Program (CNTRP). The CNTRP is a national program designed to increase organ and tissue donation in Canada and enhance the survival and quality of life of Canadians who receive transplants. As a national program, CNTRP provides robust power for pediatric studies that would not otherwise be possible. While primarily focused on issues unique to a pediatric and young adult population, this study will interact closely with all other CNTRP projects. These reciprocal interactions will accelerate new discovery that can be cross-applied in different populations outside of pre-specified age groups. Interactions will ensure rapid knowledge transfer, uptake and dissemination into practice. This is the largest national cohort study of pediatric transplant patients to date in Canada, and it will create a longitudinal dataset with clinical and biological specimens linkable to transplant registries and provincial administrative datasets.
Read the detailed description
The overall objective of this project is to analyze physiological factors that impact immune response and effect of immunosuppression across different pediatric age groups, to develop age-appropriate medical and health care strategies that can improve graft survival and reduce complications in a pediatric and young adult population. There are 3 primary aims of this study:
Aim 1: Develop age-appropriate calcineurin inhibitor (CNI) dosing for pediatric SOT patients: We hypothesize that physiologically-based (PB) modeling will enable personalized CNI dosing for infants, children and youth based on age, pharmacogenotype and immune maturity. Aim 1 deliverables include 1) a personalized physiologically-based CNI dosing algorithm in SOT; 2) validation of pediatric sensitive immunosuppression monitoring tools and their therapeutic targets; and 3) validation of immunologic assays for assessing age-specific immune responses. We anticipate that personalized CNI dosing will result in early attainment and maintenance of therapeutic drug concentrations, reduce the frequency of out-of-range concentrations post-transplant, improve safety and efficacy of immunosuppression, and reduce dependence on therapeutic drug monitoring to guide drug dosing. Standardized assessment of immune function may also monitor immunosuppression more reliably and eventually reduce the need for invasive monitoring like biopsies.
Aim 2: Develop risk prediction tools based on viral-host interactions that predispose young SOT and hematopoietic stem cell transplant patients to Epstein-Barr virus disorders/post-transplant lymphoproliferative disorder (EBV disorders/PTLD): We hypothesize that susceptibility to EBV disorders/PTLD is influenced by the interaction of high-risk EBV subtypes with host factors like age, immune maturation and intensity of immunosuppression. In the above context, "EBV disorders" refers to non-malignant EBV disease as well as sustained elevation of viral loads in the absence of PTLD. We will identify high-risk viral subtypes and age-related differences in host immunity that interact to increase susceptibility to EBV disorders/PTLD in young patients. Important clinical applications are: 1) knowledge of host susceptibility factors (age and immune maturation) at the time of transplant may assist choice of less intensive immunosuppression to reduce risk of developing EBV (e.g., avoidance of T cell depletion therapies, primary prevention) and promote use of EBV prophylaxis in at risk patients (secondary prevention); 2) an EBV genotype panel will be developed as a clinical tool for detecting high risk subtypes in patients with EBV. This will help identify patients exposed to EBV who should receive aggressive therapy for EBV and/or PTLD (personalized therapy). This innovative risk stratification will enable personalized immunosuppression strategies and strategies to prevent and treat EBV/PTLD.
Aim 3: Develop health care systems strategies to enhance medication adherence in adolescents and young adults: Medication adherence is determined by factors at a variety of different "levels": patient-level (patient-, condition-, and therapy-related factors), "micro"-level (social factors and interactions with the care team), "meso"-level (organization and expertise of the healthcare team and care processes), and "macro"-level (high-level healthcare systems factors, including care and medication cost coverage, and overall care environment). We hypothesize that there are significant differences in modifiable meso- and macro-level systems factors between pediatric programs, between adult programs, and between pediatric and adult programs. Furthermore, we hypothesize that modifiable meso- and macro-level systems factors are independently associated with medication adherence. This aim has two primary objectives:
Objective 1: To characterize differences between Canadian solid organ transplant programs in potentially modifiable meso- and macro-level systems factors.
Objective 2: To identify potentially modifiable meso- and macro-level factors that are determinants of adherence, adjusting for potential confounders.
- Conditions
- Transplant, Adaptive Immunity, EBV, Medication Adherence, PTLD
- Keywords
- Transplant, Adaptive Immunity, EBV, Medication Adherence, Tacrolimus, PTLD
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Solid organ transplant | Not described | |
| Hematopoietic Stem Cell Transplant | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tacrolimus trough blood concentrations
Measured: 1 year from time of transplant
Time to attain stable therapeutic tacrolimus trough blood concentration
Stable therapeutic blood concentration defined as two levels in target therapeutic range without change in dose.
Measured: 1 year from time of transplant
Frequency of out-of-range trough levels during follow-up
Blood concentrations will be captured at 36-48 hours post tacrolimus initiation after transplant, 7, 14, and 30 days after and 3 months and 12 months post transplant.
Measured: 1 year from time of transplant
Determination of trough target therapeutic range
Blood concentrations will be captured at 36-48 hours post tacrolimus initiation after transplant, 7, 14, and 30 days after and 3 months and 12 months post transplant.
Measured: 1 year from time of transplant
Viral genotype
Relationship between major EBV subtypes and clinical and virologic outcomes (illness severity, viral loads, PTLD), evaluated in age groups of <2 years, 2-10 years, 11-18 years and adults >18 years
Measured: 1 year from time of transplant
Taking Adherence to immunosuppressive medications measured using pharmacy refill data and structured self-report
Participant pharmacies will be contacted at end of study to determine if medications are being refilled as would be expected if all doses were consumed as prescribed.
Measured: 6 months from a minimum of 3 months post time of transplant
Immune maturation across pediatric age groups
Measured: Baseline & 1 year from time of transplant
Functional immunoassay
Baseline \& 1 year from time of transplant
Measured: 1 year from time of transplant
Change in immune function before and after transplant as it correlates with immune maturation and intensity of immunosuppression
Measured: Baseline & 1 year from time of transplant
Viral immunoassays
Measured: Baseline & 1 year from time of transplant
Secondary outcomes (6)
Graft rejection
Measured: 1 year from time of transplant
Complications (cancer, infections, CVS, CNS, other
Measured: 1 year from time of transplant
Graft outcomes
Measured: Baseline, 3 months, 6 months
Adverse events
Measured: Baseline, 3 months, 6 months
Timing adherence to immunosuppressive medications
Proportion of doses taken late by >25% of the prescribed inter-dose interval
Measured: 6 months from a minimum of 3 months post time of transplant
Drug Holidays for immunosuppressive medications
Period during which 2 or more consecutive doses were missed
Measured: 6 months from a minimum of 3 months post time of transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2019
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TransplantStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Alberta Children's Hospital, Stollery Children's Hospital, St. Justine's Hospital, The Children's Hospital of Winnipeg, Montreal Children's Hospital of the MUHC, Provincial Health Services Authority British Columbia, Toronto General Hospital, Vancouver General Hospital, Royal Victoria Hospital, Canada, The Ottawa Hospital, Foothills Medical Centre, Centre hospitalier de l'Université de Montréal (CHUM), University of British Columbia
- Responsible party
- Principal investigator, Seema Mital, The Hospital for Sick Children
- Investigators
- Seema Mital, MD, Principal investigator, SickKids Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318030
- Sponsor's protocol ID
- 1000045186
- Status last verified
- Sep 2021
- First submitted
- 25 Nov 2014
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Papaz T, Allen U, Blydt-Hansen T, Birk PE, Min S, Hamiwka L, Phan V, Schechter T, Wall DA, Urschel S, Foster BJ, Mital S. Pediatric Outcomes in Transplant: PersOnaliSing Immunosuppression To ImproVe Efficacy (POSITIVE Study): The Collaboration and Design of a National Transplant Precision Medicine Program. Transplant Direct. 2018 Nov 27;4(12):e410. doi: 10.1097/TXD.0000000000000842. eCollection 2018 Dec.
PubMed 30584591Min S, Papaz T, Lambert AN, Allen U, Birk P, Blydt-Hansen T, Foster BJ, Grasemann H, Hamiwka L, Litalien C, Ng V, Berka N, Campbell P, Daniel C, Saw CL, Tinckam K, Urschel S, Van Driest SL, Parekh R, Mital S. An Integrated Clinical and Genetic Prediction Model for Tacrolimus Levels in Pediatric Solid Organ Transplant Recipients. Transplantation. 2022 Mar 1;106(3):597-606. doi: 10.1097/TP.0000000000003700.
PubMed 33755393Dabirzadeh A, Dahhou M, Zhang X, Sapir-Pichhadze R, Cardinal H, White M, Johnston O, Blydt-Hansen TD, Tibbles LA, Hamiwka L, Urschel S, Birk P, Bissonnette J, Matsuda-Abedini M, Harrison J, Schiff J, Phan V, De Geest S, Allen U, Mital S, Foster BJ. Care processes and structures associated with higher medication adherence in adolescent and young adult transplant recipients. Pediatr Transplant. 2021 Dec;25(8):e14106. doi: 10.1111/petr.14106. Epub 2021 Aug 2.
PubMed 34339090
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CNTRP Paediatric Outcomes in Transplant: Personalising Immunosuppression to Improve Efficacy (POSITIVE Study)
- ClinicalTrials.gov ID
- NCT02318030
- Acronym / sponsor ID
- 1000045186
- Conditions
- Transplant, Adaptive Immunity, EBV, Medication Adherence, PTLD
- Keywords
- Transplant, Adaptive Immunity, EBV, Medication Adherence, Tacrolimus, PTLD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Alberta Children's Hospital, Stollery Children's Hospital, St. Justine's Hospital, The Children's Hospital of Winnipeg, Montreal Children's Hospital of the MUHC, Provincial Health Services Authority British Columbia, Toronto General Hospital, Vancouver General Hospital, Royal Victoria Hospital, Canada, The Ottawa Hospital, Foothills Medical Centre, Centre hospitalier de l'Université de Montréal (CHUM), University of British Columbia
- Study start
- Apr 2014 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 17 Dec 2014 (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.
Adequate control of immunosuppression is critical in preventing graft failure after solid organ transplantation (SOT) and in avoiding life-threatening viral and malignant complications. Prolonging patient and graft survival and delaying re-transplantation as children reach adulthood is critical to optimal use of a scarce resource. This requires tailoring post-transplant management to the unique needs of the child. Immunosuppression management is challenging in infants, children and youth. The interval from birth to young adulthood sees profound changes in physiological processes, body size and immune maturation; infancy and adolescence are the periods of most rapid and dramatic change. Three pivotal factors affect immunosuppression control in the child: 1) age-dependent variation in drug metabolism; 2) developmental changes in immune function with increased childhood susceptibility to infections, including those caused by viruses; and 3) behavioural changes in adolescence and young adulthood linked with poor treatment adherence.
This project will identify the most important factors influencing immunosuppression control across the pediatric age range, from infancy to young adulthood, including age-related changes in drug metabolism, immune function, and susceptibility to viral infections, as well as health care system factors affecting treatment adherence. This is the first comprehensive, multi-organ transplant study to identify age-related biologic and health care systems determinants of variability in immunosuppression control in children and youth. Results will inform personalized age-appropriate strategies to improve immunosuppression control and reduce the unacceptably high graft failure and viral complication rates in this vulnerable population.
The POSITIVE Study brings together researchers across Canada and is one of 6 projects and 3 cores that constitute the Canadian Institute of Health Research (CIHR) funded interdisciplinary research program called the Canadian National Transplant Research Program (CNTRP). The CNTRP is a national program designed to increase organ and tissue donation in Canada and enhance the survival and quality of life of Canadians who receive transplants. As a national program, CNTRP provides robust power for pediatric studies that would not otherwise be possible. While primarily focused on issues unique to a pediatric and young adult population, this study will interact closely with all other CNTRP projects. These reciprocal interactions will accelerate new discovery that can be cross-applied in different populations outside of pre-specified age groups. Interactions will ensure rapid knowledge transfer, uptake and dissemination into practice. This is the largest national cohort study of pediatric transplant patients to date in Canada, and it will create a longitudinal dataset with clinical and biological specimens linkable to transplant registries and provincial administrative datasets.
Detailed description
The overall objective of this project is to analyze physiological factors that impact immune response and effect of immunosuppression across different pediatric age groups, to develop age-appropriate medical and health care strategies that can improve graft survival and reduce complications in a pediatric and young adult population. There are 3 primary aims of this study:
Aim 1: Develop age-appropriate calcineurin inhibitor (CNI) dosing for pediatric SOT patients: We hypothesize that physiologically-based (PB) modeling will enable personalized CNI dosing for infants, children and youth based on age, pharmacogenotype and immune maturity. Aim 1 deliverables include 1) a personalized physiologically-based CNI dosing algorithm in SOT; 2) validation of pediatric sensitive immunosuppression monitoring tools and their therapeutic targets; and 3) validation of immunologic assays for assessing age-specific immune responses. We anticipate that personalized CNI dosing will result in early attainment and maintenance of therapeutic drug concentrations, reduce the frequency of out-of-range concentrations post-transplant, improve safety and efficacy of immunosuppression, and reduce dependence on therapeutic drug monitoring to guide drug dosing. Standardized assessment of immune function may also monitor immunosuppression more reliably and eventually reduce the need for invasive monitoring like biopsies.
Aim 2: Develop risk prediction tools based on viral-host interactions that predispose young SOT and hematopoietic stem cell transplant patients to Epstein-Barr virus disorders/post-transplant lymphoproliferative disorder (EBV disorders/PTLD): We hypothesize that susceptibility to EBV disorders/PTLD is influenced by the interaction of high-risk EBV subtypes with host factors like age, immune maturation and intensity of immunosuppression. In the above context, "EBV disorders" refers to non-malignant EBV disease as well as sustained elevation of viral loads in the absence of PTLD. We will identify high-risk viral subtypes and age-related differences in host immunity that interact to increase susceptibility to EBV disorders/PTLD in young patients. Important clinical applications are: 1) knowledge of host susceptibility factors (age and immune maturation) at the time of transplant may assist choice of less intensive immunosuppression to reduce risk of developing EBV (e.g., avoidance of T cell depletion therapies, primary prevention) and promote use of EBV prophylaxis in at risk patients (secondary prevention); 2) an EBV genotype panel will be developed as a clinical tool for detecting high risk subtypes in patients with EBV. This will help identify patients exposed to EBV who should receive aggressive therapy for EBV and/or PTLD (personalized therapy). This innovative risk stratification will enable personalized immunosuppression strategies and strategies to prevent and treat EBV/PTLD.
Aim 3: Develop health care systems strategies to enhance medication adherence in adolescents and young adults: Medication adherence is determined by factors at a variety of different "levels": patient-level (patient-, condition-, and therapy-related factors), "micro"-level (social factors and interactions with the care team), "meso"-level (organization and expertise of the healthcare team and care processes), and "macro"-level (high-level healthcare systems factors, including care and medication cost coverage, and overall care environment). We hypothesize that there are significant differences in modifiable meso- and macro-level systems factors between pediatric programs, between adult programs, and between pediatric and adult programs. Furthermore, we hypothesize that modifiable meso- and macro-level systems factors are independently associated with medication adherence. This aim has two primary objectives:
Objective 1: To characterize differences between Canadian solid organ transplant programs in potentially modifiable meso- and macro-level systems factors.
Objective 2: To identify potentially modifiable meso- and macro-level factors that are determinants of adherence, adjusting for potential confounders.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solid organ transplant | – | – |
| Hematopoietic Stem Cell Transplant | – | – |
Who may qualify
- Ages
- 0 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- End stage organ failure, Solid organ transplant
Key inclusion criteria (11 listed)
- Aim 1
- Listed for or recipient of solid organ transplant
- Planned immunosuppression with oral or enteral tacrolimus post-transplant
- Aim 2
- Solid organ transplant or hematopoietic stem cell transplant recipients <18 years old
Key exclusion criteria (0 listed)
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
Tacrolimus trough blood concentrations
Time frame: 1 year from time of transplant
Time to attain stable therapeutic tacrolimus trough blood concentration
Time frame: 1 year from time of transplant
Stable therapeutic blood concentration defined as two levels in target therapeutic range without change in dose.
Frequency of out-of-range trough levels during follow-up
Time frame: 1 year from time of transplant
Blood concentrations will be captured at 36-48 hours post tacrolimus initiation after transplant, 7, 14, and 30 days after and 3 months and 12 months post transplant.
Determination of trough target therapeutic range
Time frame: 1 year from time of transplant
Blood concentrations will be captured at 36-48 hours post tacrolimus initiation after transplant, 7, 14, and 30 days after and 3 months and 12 months post transplant.
Viral genotype
Time frame: 1 year from time of transplant
Relationship between major EBV subtypes and clinical and virologic outcomes (illness severity, viral loads, PTLD), evaluated in age groups of <2 years, 2-10 years, 11-18 years and adults >18 years
Taking Adherence to immunosuppressive medications measured using pharmacy refill data and structured self-report
Time frame: 6 months from a minimum of 3 months post time of transplant
Participant pharmacies will be contacted at end of study to determine if medications are being refilled as would be expected if all doses were consumed as prescribed.
Immune maturation across pediatric age groups
Time frame: Baseline & 1 year from time of transplant
Functional immunoassay
Time frame: 1 year from time of transplant
Baseline \& 1 year from time of transplant
Change in immune function before and after transplant as it correlates with immune maturation and intensity of immunosuppression
Time frame: Baseline & 1 year from time of transplant
Viral immunoassays
Time frame: Baseline & 1 year from time of transplant
6 secondary outcomes
Graft rejection
Time frame: 1 year from time of transplant
Complications (cancer, infections, CVS, CNS, other
Time frame: 1 year from time of transplant
Graft outcomes
Time frame: Baseline, 3 months, 6 months
Adverse events
Time frame: Baseline, 3 months, 6 months
Timing adherence to immunosuppressive medications
Time frame: 6 months from a minimum of 3 months post time of transplant
Drug Holidays for immunosuppressive medications
Time frame: 6 months from a minimum of 3 months post time of transplant
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 8 Oct 2021.
- Background: PubMed 30584591Papaz T, Allen U, Blydt-Hansen T, Birk PE, Min S, Hamiwka L, Phan V, Schechter T, Wall DA, Urschel S, Foster BJ, Mital S. Pediatric Outcomes in Transplant: PersOnaliSing Immunosuppression To ImproVe Efficacy (POSITIVE Study): The Collaboration and Design of a National Transplant Precision Medicine Program. Transplant Direct. 2018 Nov 27;4(12):e410. doi: 10.1097/TXD.0000000000000842. eCollection 2018 Dec.
- Results publication: PubMed 33755393Min S, Papaz T, Lambert AN, Allen U, Birk P, Blydt-Hansen T, Foster BJ, Grasemann H, Hamiwka L, Litalien C, Ng V, Berka N, Campbell P, Daniel C, Saw CL, Tinckam K, Urschel S, Van Driest SL, Parekh R, Mital S. An Integrated Clinical and Genetic Prediction Model for Tacrolimus Levels in Pediatric Solid Organ Transplant Recipients. Transplantation. 2022 Mar 1;106(3):597-606. doi: 10.1097/TP.0000000000003700.
- Results publication: PubMed 34339090Dabirzadeh A, Dahhou M, Zhang X, Sapir-Pichhadze R, Cardinal H, White M, Johnston O, Blydt-Hansen TD, Tibbles LA, Hamiwka L, Urschel S, Birk P, Bissonnette J, Matsuda-Abedini M, Harrison J, Schiff J, Phan V, De Geest S, Allen U, Mital S, Foster BJ. Care processes and structures associated with higher medication adherence in adolescent and young adult transplant recipients. Pediatr Transplant. 2021 Dec;25(8):e14106. doi: 10.1111/petr.14106. Epub 2021 Aug 2.
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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.
Seema Mital, MD principal investigator
SickKids Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant and Adaptive Immunity, run by The Hospital for Sick Children at 1 site in Canada.
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 11 inclusion and 0 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 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Tacrolimus trough blood concentrations (time frame: 1 year from time of transplant). The study lists 10 primary outcomes in all. 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 NCT02318030, which also lists 3 linked publications.
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 8 Oct 2021.