Kidney Transplant RejectionEarly Phase 1NCT04156204
Immunosuppressant Medication Dosed Daily After Kidney Transplant
A Early Phase 1 study testing Medication Event Monitoring System (MEMS) and Once-Daily Tacrolimus extended release in people with Kidney Transplant Rejection and Medication Adherence, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Medication non-adherence is a major risk factor for graft dysfunction and graft loss among pediatric and adult transplant recipients. Rates of non-adherence in these populations are estimated between 30 and 70%, with the highest prevalence in adolescent and young adult (AYA) transplant recipients. Read more about this study
- Who is it for?
- Ages 13 to 22 years
- Conditions the study is for
- Kidney Transplant Rejection, Medication Adherence
- What is being tested?
- Medication Event Monitoring System (MEMS) and Once-Daily Tacrolimus extended release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2019to 27 Nov 2020
- Phase
- Early Phase 1
- 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 13 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 13-22 years
- Tanner stage 4/5
- "Stable" kidney transplant status, as determined by the primary transplant team
- At minimum 1 year post-kidney transplant or patients meeting all of the above inclusion criteria except 4) who have instead been transitioned to azathioprine by the primary transplant team due to intolerability of mycophenolate mofetil secondary to adverse medication effects (i.e. neutropenia, gastrointestinal intolerance etc.)
Who cannot join
- < Tanner stage 4
- Kidney transplant performed at an institution other than Children's Hospital Colorado, Lurie Children's Hospital of Chicago, or Cincinnati Children's Hospital
- Recipients of dual solid organ transplants (i.e. heart kidney, liver kidney).
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Kidney Immunosuppression Dosed Daily Only (KIDDO) - A Pilot Study
Medication non-adherence is a major risk factor for graft dysfunction and graft loss among pediatric and adult transplant recipients. Rates of non-adherence in these populations are estimated between 30 and 70%, with the highest prevalence in adolescent and young adult (AYA) transplant recipients. Treatment-related factors known to impact rates of adherence include the number of medication doses per day and the number of tablets or capsules a patient takes per day, or "pill burden". One approach to minimizing dosing frequency and pill-burden includes transitioning patients to once-daily formulations. The current literature investigating utilization of once-daily immunosuppressive regimens in the AYA kidney transplant population is limited.
Read the detailed description
One approach to minimizing dosing frequency and pill-burden includes transitioning patients to once-daily formulations.3 The current literature investigating utilization of once-daily immunosuppressive regimens in the AYA kidney transplant population is limited. Two studies have demonstrated safe and effective conversion of twice-daily tacrolimus to the Astagraf® in stable pediatric solid organ transplant recipients.4,5 Patients maintained equivalent tacrolimus exposure and experienced similar rates of rejection and graft loss in the first year post-conversion.5 To date, experience with another once-daily extended release (XR) tacrolimus product, Envarsus XR®, has not been published in the AYA population. Additionally, adherence studies evaluating a once-daily immunosuppression regimen including extended-release tacrolimus and azathioprine (which is dosed once daily as opposed to the twice daily dosing required for azathioprine's alternative mycophenolate mofetil) have not been conducted.
Of note, and even though twice-daily mycophenolate has been shown to be superior to once-daily azathioprine early post-transplant, more long-term data suggest that this advantage may not persist.6 Furthermore, a recent Cochrane review addressed the question of mycophenolate versus azathioprine as primary anti-proliferative immunosuppression for kidney transplant recipients; it concluded that "balancing the benefits and harms of the two drugs remains a major task of the transplant physician to decide which agent" is appropriate for the individual patient. 7 Moreover, once-daily immunosuppression with tacrolimus extended-release and once-daily azathioprine has been used with excellent results at a British center that focusses on AYA kidney transplant recipients.
- Conditions
- Kidney Transplant Rejection, Medication Adherence
- Being tested
- Medication Event Monitoring System (MEMS), Once-Daily Tacrolimus extended release
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Event Monitoring System (MEMS)Other
AYA kidney recipients will receive a Medication Event Monitoring System (MEMS) via medication bottle and cap system
Once-Daily Tacrolimus extended releaseDrug
Also called Envarus XR
AYA kidney recipients will receive once daily tacrolimus XR 1-10mg daily
| Study group | Role | What they receive |
|---|---|---|
| Adolescent and Young Adult (AYA) Kidney Transplant Recipients | Experimental | AYA kidney transplant recipients will receive a Medication Event Monitoring System (MEMS) in the form of a medication bottle and cap system and once daily tacrolimus XR 1-10mg Receives: Other: Medication Event Monitoring System (MEMS); Drug: Once-Daily Tacrolimus extended release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life: as assessed by change in PedsQL
Pediatric Quality of Life (PedsQL) Transplant Module Version 3.0 will be used to assess quality of life prior to and after transition from twice to once daily immunosuppressant medication regimen. Health-related quality of life (HRQOL) has been defined as an individual's subjective experience of their illness, and the impact that illness and its treatment have on the individual's functioning in a variety of domains. The PedsQL is a 46-item self- and parent-report measure that rates HRQOL in 8 domains (medication adherence, medication side-effects, social relationship, physical discomfort, worries regarding health status, treatment anxiety, impact on appearance, and communication). The PedsQL Transplant Module assesses physical functioning, emotional functioning, social functioning, and school functioning and was developed through focus groups, cognitive interviews, pretesting, and field testing measurement development protocols. Higher scores indicate lower problems.
Measured: Day 0, Day 60, Day 210
Adherence to medical therapies and medications: as assessed by Medication Event Monitoring System (MEMS) at Day 30
MEMS data will be accessed prior to transition to once-daily medications (baseline adherence) and analyzed accordingly. Dates and times in which medication bottles were opened will be recorded.
Measured: Day 30
Adherence to medical therapies and medications: as assessed by Medication Event Monitoring System (MEMS) at Day 60
MEMS data will be accessed the first month of transition to once-daily medications (intervention adherence) and analyzed accordingly. Dates and times in which medication bottles were opened will be recorded.
Measured: Day 60
Adherence to medical therapies and medications: as assessed by Medication Event Monitoring System (MEMS) at Day 210
MEMS data will be accessed 6 months after transition to once-daily medications (retention adherence) and analyzed accordingly. Dates and times in which medication bottles were opened will be recorded.
Measured: Day 210
Adherence to medical therapies and medications: as assessed by Change in Tacrolimus Trough Concentration Variance
Tacrolimus trough goals between 4-7ng/mL as per Transplant Immunosuppression Protocols. Student T-test, repeated measures for parametric data).
The standard deviation of tacrolimus troughs will be calculated from the 4 tacrolimus trough values obtained for clinical care purposes preceding Study Visit 1 (SD1). The standard deviation of tacrolimus troughs will be calculated again from the 4 tacrolimus trough values obtained for clinical care purposes preceding Study Visit 4 (SD2).
Measured: Day 0, Day 30, Day 60, and Day 240
Adherence to medical therapies and medications:as assessed by Change in Adolescent Medication Barriers Scale (AMBS)
17 item scale that corresponds to the Parent Medication Barriers Scale (PMBS) with 16 items. Both have strong internal consistency and are scored on a 5-point Likert scale from Strongly Disagree to Strongly Agree. A total score can be calculated, and there are subdomains of disease frustration/adolescent issues, regimen adaptation/cognitive issues, and ingestion issues, with an additional parent reminder domain on the PMBS. Lower scores indicate less barriers to medication adherence.
Measured: Day 0, Day 60, Day 210
Adherence to medical therapies and medications: as assessed by Change in The Medical Adherence Measure (MAM)
Semi-structured interview that has four general modules to assess adherence with medication, diet, exercise, and clinic attendance, as well as illness-specific modules. For the purpose of this study, the Medication and Clinic Attendance Modules will be completed. Non-adherence scores can be calculated based on the degree of adherence on a spectrum of 0%-100% adherent to capture the fluctuations and intricacies of occasional or slightly inconsistent adherence. Missed adherence score = number of doses missed out of the doses prescribed × 100%. Late adherence score = number of doses taken late out of the doses prescribed × 100%, where late is defined as greater than one hour later than the usual routine. Adherence is assessed for each medication separately and then averaged across medications.
Measured: Day 0, Day 60, Day 210
Secondary outcomes (5)
Long-term measures of graft and patient survival: as assessed by change in serum creatinine and urinary protein
Markers of graft function will be assessed by measuring levels of serum creatinine and urinary protein. Lower serum creatinine and urinary protein indicate better long-term graft and patient survival.
Measured: Day 0, Day 30, Day 60, Day 210, and Day 240
Long-term measures of graft and patient survival: as assessed by change in markers of proteinuria
Markers of proteinuria will be assessed by urinalysis and random urinary protein/creatinine ratio. Lower urinary protein/creatinine ratio indicates better long-term measures of graft and patient survival.
Measured: Day 30 and Day 210
Long-term measures of graft and patient survival: as assessed by number of episodes of rejection
Graft rejection episodes will be determined to have occurred if indicated by transplant biopsy results. Occurrences of graft rejection episodes among participants will be assessed up to Day 240.
Measured: Up to Day 240
Long-term measures of graft and patient survival: as assessed by change in presence of donor-specific antibody monitoring
Presence of donor-specific antibodies (DSA) prior to and after initiation of intervention.
Measured: Day 0 and Day 240
Long-term measures of graft and patient survival: as assessed by change in presence of BK virus screening results
Includes assessing the viral load to monitor presence of BK virus.
Measured: Day 0 and Day 240
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start20 Nov 2019
- Primary completion27 Nov 2020
- Study completion27 Nov 2020
Why it stopped: Discontinuation of study due to site staffing and resources available to conduct the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal Pilot Study
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Goebel, MD, Principal investigator, Children's Hospital ColoradoMary Chandran, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156204
- Sponsor's protocol ID
- 17-2311
- Status last verified
- Nov 2020
- First submitted
- 1 Nov 2019
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Foster BJ, Dahhou M, Zhang X, Platt RW, Samuel SM, Hanley JA. Association between age and graft failure rates in young kidney transplant recipients. Transplantation. 2011 Dec 15;92(11):1237-43. doi: 10.1097/TP.0b013e31823411d7.
PubMed 22124283Burkhart PV, Sabate E. Adherence to long-term therapies: evidence for action. J Nurs Scholarsh. 2003;35(3):207. No abstract available.
PubMed 14562485Steinberg EA, Moss M, Buchanan CL, Goebel J. Adherence in pediatric kidney transplant recipients: solutions for the system. Pediatr Nephrol. 2018 Mar;33(3):361-372. doi: 10.1007/s00467-017-3637-0. Epub 2017 Mar 27.
PubMed 28349215Min SI, Ha J, Kang HG, Ahn S, Park T, Park DD, Kim SM, Hong HJ, Min SK, Ha IS, Kim SJ. Conversion of twice-daily tacrolimus to once-daily tacrolimus formulation in stable pediatric kidney transplant recipients: pharmacokinetics and efficacy. Am J Transplant. 2013 Aug;13(8):2191-7. doi: 10.1111/ajt.12274. Epub 2013 Jun 4.
PubMed 23734831Heffron TG, Pescovitz MD, Florman S, Kalayoglu M, Emre S, Smallwood G, Wisemandle K, Anania C, Dhadda S, Sawamoto T, Keirns J, Fitzsimmons W, First MR. Once-daily tacrolimus extended-release formulation: 1-year post-conversion in stable pediatric liver transplant recipients. Am J Transplant. 2007 Jun;7(6):1609-15. doi: 10.1111/j.1600-6143.2007.01803.x.
PubMed 17511684Clayton PA, McDonald SP, Chapman JR, Chadban SJ. Mycophenolate versus azathioprine for kidney transplantation: a 15-year follow-up of a randomized trial. Transplantation. 2012 Jul 27;94(2):152-8. doi: 10.1097/TP.0b013e31825475a3.
PubMed 22728292Wagner M, Earley AK, Webster AC, Schmid CH, Balk EM, Uhlig K. Mycophenolic acid versus azathioprine as primary immunosuppression for kidney transplant recipients. Cochrane Database Syst Rev. 2015 Dec 3;2015(12):CD007746. doi: 10.1002/14651858.CD007746.pub2.
PubMed 26633102
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney Immunosuppression Dosed Daily Only (KIDDO) - A Pilot Study
- ClinicalTrials.gov ID
- NCT04156204
- Acronym / sponsor ID
- 17-2311
- Conditions
- Kidney Transplant Rejection, Medication Adherence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinuation of study due to site staffing and resources available to conduct the study
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 27 Nov 2020 (actual)
- Study completion
- 27 Nov 2020 (actual)
- First posted
- 7 Nov 2019 (actual)
- 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.
Medication non-adherence is a major risk factor for graft dysfunction and graft loss among pediatric and adult transplant recipients. Rates of non-adherence in these populations are estimated between 30 and 70%, with the highest prevalence in adolescent and young adult (AYA) transplant recipients. Treatment-related factors known to impact rates of adherence include the number of medication doses per day and the number of tablets or capsules a patient takes per day, or "pill burden". One approach to minimizing dosing frequency and pill-burden includes transitioning patients to once-daily formulations. The current literature investigating utilization of once-daily immunosuppressive regimens in the AYA kidney transplant population is limited.
Detailed description
One approach to minimizing dosing frequency and pill-burden includes transitioning patients to once-daily formulations.3 The current literature investigating utilization of once-daily immunosuppressive regimens in the AYA kidney transplant population is limited. Two studies have demonstrated safe and effective conversion of twice-daily tacrolimus to the Astagraf® in stable pediatric solid organ transplant recipients.4,5 Patients maintained equivalent tacrolimus exposure and experienced similar rates of rejection and graft loss in the first year post-conversion.5 To date, experience with another once-daily extended release (XR) tacrolimus product, Envarsus XR®, has not been published in the AYA population. Additionally, adherence studies evaluating a once-daily immunosuppression regimen including extended-release tacrolimus and azathioprine (which is dosed once daily as opposed to the twice daily dosing required for azathioprine's alternative mycophenolate mofetil) have not been conducted.
Of note, and even though twice-daily mycophenolate has been shown to be superior to once-daily azathioprine early post-transplant, more long-term data suggest that this advantage may not persist.6 Furthermore, a recent Cochrane review addressed the question of mycophenolate versus azathioprine as primary anti-proliferative immunosuppression for kidney transplant recipients; it concluded that "balancing the benefits and harms of the two drugs remains a major task of the transplant physician to decide which agent" is appropriate for the individual patient. 7 Moreover, once-daily immunosuppression with tacrolimus extended-release and once-daily azathioprine has been used with excellent results at a British center that focusses on AYA kidney transplant recipients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Adolescent and Young Adult (AYA) Kidney Transplant Recipients | Experimental | Other: Medication Event Monitoring System (MEMS), Drug: Once-Daily Tacrolimus extended releaseAYA kidney transplant recipients will receive a Medication Event Monitoring System (MEMS) in the form of a medication bottle and cap system and once daily tacrolimus XR 1-10mg |
Who may qualify
- Ages
- 13 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 13-22 years
- Tanner stage 4/5
- "Stable" kidney transplant status, as determined by the primary transplant team
- At minimum 1 year post-kidney transplant or patients meeting all of the above inclusion criteria except 4) who have instead been transitioned to azathioprine by the primary transplant team due to intolerability of mycophenolate mofetil secondary to adverse medication effects (i.e. neutropenia, gastrointestinal intolerance etc.)
Key exclusion criteria (3 listed)
- < Tanner stage 4
- Kidney transplant performed at an institution other than Children's Hospital Colorado, Lurie Children's Hospital of Chicago, or Cincinnati Children's Hospital
- Recipients of dual solid organ transplants (i.e. heart kidney, liver kidney).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication Event Monitoring System (MEMS)AYA kidney recipients will receive a Medication Event Monitoring System (MEMS) via medication bottle and cap system | Other | Adolescent and Young Adult (AYA) Kidney Transplant Recipients |
| Once-Daily Tacrolimus extended releaseAlso: Envarus XRAYA kidney recipients will receive once daily tacrolimus XR 1-10mg daily | Drug | Adolescent and Young Adult (AYA) Kidney Transplant Recipients |
Primary outcome
Health-Related Quality of Life: as assessed by change in PedsQL
Time frame: Day 0, Day 60, Day 210
Pediatric Quality of Life (PedsQL) Transplant Module Version 3.0 will be used to assess quality of life prior to and after transition from twice to once daily immunosuppressant medication regimen. Health-related quality of life (HRQOL) has been defined as an individual's subjective experience of their illness, and the impact that illness and its treatment have on the individual's functioning in a variety of domains. The PedsQL is a 46-item self- and parent-report measure that rates HRQOL in 8 domains (medication adherence, medication side-effects, social relationship, physical discomfort, worries regarding health status, treatment anxiety, impact on appearance, and communication). The PedsQL Transplant Module assesses physical functioning, emotional functioning, social functioning, and school functioning and was developed through focus groups, cognitive interviews, pretesting, and field testing measurement development protocols. Higher scores indicate lower problems.
Adherence to medical therapies and medications: as assessed by Medication Event Monitoring System (MEMS) at Day 30
Time frame: Day 30
MEMS data will be accessed prior to transition to once-daily medications (baseline adherence) and analyzed accordingly. Dates and times in which medication bottles were opened will be recorded.
Adherence to medical therapies and medications: as assessed by Medication Event Monitoring System (MEMS) at Day 60
Time frame: Day 60
MEMS data will be accessed the first month of transition to once-daily medications (intervention adherence) and analyzed accordingly. Dates and times in which medication bottles were opened will be recorded.
Adherence to medical therapies and medications: as assessed by Medication Event Monitoring System (MEMS) at Day 210
Time frame: Day 210
MEMS data will be accessed 6 months after transition to once-daily medications (retention adherence) and analyzed accordingly. Dates and times in which medication bottles were opened will be recorded.
Adherence to medical therapies and medications: as assessed by Change in Tacrolimus Trough Concentration Variance
Time frame: Day 0, Day 30, Day 60, and Day 240
Tacrolimus trough goals between 4-7ng/mL as per Transplant Immunosuppression Protocols. Student T-test, repeated measures for parametric data). The standard deviation of tacrolimus troughs will be calculated from the 4 tacrolimus trough values obtained for clinical care purposes preceding Study Visit 1 (SD1). The standard deviation of tacrolimus troughs will be calculated again from the 4 tacrolimus trough values obtained for clinical care purposes preceding Study Visit 4 (SD2).
Adherence to medical therapies and medications:as assessed by Change in Adolescent Medication Barriers Scale (AMBS)
Time frame: Day 0, Day 60, Day 210
17 item scale that corresponds to the Parent Medication Barriers Scale (PMBS) with 16 items. Both have strong internal consistency and are scored on a 5-point Likert scale from Strongly Disagree to Strongly Agree. A total score can be calculated, and there are subdomains of disease frustration/adolescent issues, regimen adaptation/cognitive issues, and ingestion issues, with an additional parent reminder domain on the PMBS. Lower scores indicate less barriers to medication adherence.
Adherence to medical therapies and medications: as assessed by Change in The Medical Adherence Measure (MAM)
Time frame: Day 0, Day 60, Day 210
Semi-structured interview that has four general modules to assess adherence with medication, diet, exercise, and clinic attendance, as well as illness-specific modules. For the purpose of this study, the Medication and Clinic Attendance Modules will be completed. Non-adherence scores can be calculated based on the degree of adherence on a spectrum of 0%-100% adherent to capture the fluctuations and intricacies of occasional or slightly inconsistent adherence. Missed adherence score = number of doses missed out of the doses prescribed × 100%. Late adherence score = number of doses taken late out of the doses prescribed × 100%, where late is defined as greater than one hour later than the usual routine. Adherence is assessed for each medication separately and then averaged across medications.
5 secondary outcomes
Long-term measures of graft and patient survival: as assessed by change in serum creatinine and urinary protein
Time frame: Day 0, Day 30, Day 60, Day 210, and Day 240
Long-term measures of graft and patient survival: as assessed by change in markers of proteinuria
Time frame: Day 30 and Day 210
Long-term measures of graft and patient survival: as assessed by number of episodes of rejection
Time frame: Up to Day 240
Long-term measures of graft and patient survival: as assessed by change in presence of donor-specific antibody monitoring
Time frame: Day 0 and Day 240
Long-term measures of graft and patient survival: as assessed by change in presence of BK virus screening results
Time frame: Day 0 and Day 240
Results and safety
The study was stopped early (reason given: Discontinuation of study due to site staffing and resources available to conduct the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Background: PubMed 22124283Foster BJ, Dahhou M, Zhang X, Platt RW, Samuel SM, Hanley JA. Association between age and graft failure rates in young kidney transplant recipients. Transplantation. 2011 Dec 15;92(11):1237-43. doi: 10.1097/TP.0b013e31823411d7.
- Background: PubMed 14562485Burkhart PV, Sabate E. Adherence to long-term therapies: evidence for action. J Nurs Scholarsh. 2003;35(3):207. No abstract available.
- Background: PubMed 28349215Steinberg EA, Moss M, Buchanan CL, Goebel J. Adherence in pediatric kidney transplant recipients: solutions for the system. Pediatr Nephrol. 2018 Mar;33(3):361-372. doi: 10.1007/s00467-017-3637-0. Epub 2017 Mar 27.
- Background: PubMed 23734831Min SI, Ha J, Kang HG, Ahn S, Park T, Park DD, Kim SM, Hong HJ, Min SK, Ha IS, Kim SJ. Conversion of twice-daily tacrolimus to once-daily tacrolimus formulation in stable pediatric kidney transplant recipients: pharmacokinetics and efficacy. Am J Transplant. 2013 Aug;13(8):2191-7. doi: 10.1111/ajt.12274. Epub 2013 Jun 4.
- Background: PubMed 17511684Heffron TG, Pescovitz MD, Florman S, Kalayoglu M, Emre S, Smallwood G, Wisemandle K, Anania C, Dhadda S, Sawamoto T, Keirns J, Fitzsimmons W, First MR. Once-daily tacrolimus extended-release formulation: 1-year post-conversion in stable pediatric liver transplant recipients. Am J Transplant. 2007 Jun;7(6):1609-15. doi: 10.1111/j.1600-6143.2007.01803.x.
- Background: PubMed 22728292Clayton PA, McDonald SP, Chapman JR, Chadban SJ. Mycophenolate versus azathioprine for kidney transplantation: a 15-year follow-up of a randomized trial. Transplantation. 2012 Jul 27;94(2):152-8. doi: 10.1097/TP.0b013e31825475a3.
- Background: PubMed 26633102Wagner M, Earley AK, Webster AC, Schmid CH, Balk EM, Uhlig K. Mycophenolic acid versus azathioprine as primary immunosuppression for kidney transplant recipients. Cochrane Database Syst Rev. 2015 Dec 3;2015(12):CD007746. doi: 10.1002/14651858.CD007746.pub2.
- Individual participant dataSharing planned: No
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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.
Jens Goebel, MD principal investigator
Children's Hospital Colorado
Mary Chandran, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Medication Event Monitoring System (MEMS) and Once-Daily Tacrolimus extended release in people with Kidney Transplant Rejection and Medication Adherence, run by University of Colorado, Denver at 1 site 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 3 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: stopped early, as of the sponsor's last update on 2 Dec 2020. 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 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Discontinuation of study due to site staffing and resources available to conduct the study). Results are not available in the source record.
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?
Health-Related Quality of Life: as assessed by change in PedsQL (time frame: Day 0, Day 60, Day 210). The study lists 7 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 NCT04156204, which also lists 7 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 2 Dec 2020.