Medication AdherenceNCT04711291
Efficacy of Envarsus XR and Digital Health Technology in Reducing Tacrolimus Fluctuation and Frequency of Dose Changes
A study testing Conversion to Envarsus-XR and use of smart phone app, TransMedAx and Convert to Envarsus XR once daily in people with Medication Adherence and Renal Transplant, run by Beth Israel Deaconess Medical Center.
Trial summary
Tacrolimus is an immunosuppressive agent prescribed to prevent organ rejection in post transplant patients, in combination with other immunosuppressants. In post-kidney transplant patients, tacrolimus blood trough(peak) level must be monitored frequently, and dose adjustments must be made as necessary to keep trough… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence, Renal Transplant
- What is being tested?
- Conversion to Envarsus-XR and use of smart phone app, TransMedAx and Convert to Envarsus XR once daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 1 Jul 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BIDMC adult kidney transplant recipient more than 2 years post transplant
- On tacrolimus IR regimen
- Estimated glomerular filtration rate (eGFR) >45
- Tacrolimus dose adjustments 2 or more times in past 12 months
- Own and able to use a smart phone.
- Able to consent
Who cannot join
- Prisoners
- Patients with primary language other than English, Spanish, Haitian/Creole, Mandarin
- Patients who can't swallow whole tablets or capsules.
About this study
Tacrolimus is an immunosuppressive agent prescribed to prevent organ rejection in post transplant patients, in combination with other immunosuppressants. In post-kidney transplant patients, tacrolimus blood trough(peak) level must be monitored frequently, and dose adjustments must be made as necessary to keep trough level within a very narrow target range.
High tacrolimus intra-patient variability(IPV) can be a marker of medication non-adherence. The presence of medication non-adherence could be due to multiple factors e.g. Forgetfulness, misunderstanding or miscommunication due to language barrier etc. Our hypothesis is using QR code technology along with extended release Tacrolimus medication will reduce tacrolimus IPV fluctuation.
Read the detailed description
Tacrolimus is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants. Envarsus XR (extended release tacrolimus) is a long acting form of tacrolimus that is prescribed as a single dose per day (every 24 hours) rather than immediate release tacrolimus (IR-Tac) which is prescribed as a two doses per day (every 12 hours).
In post-kidney transplant patients, tacrolimus blood trough level must be monitored frequently, and dose adjustments must be made as necessary to keep trough level within a very narrow therapeutic range. High intra-patient variability (IPV) has also been reported to promote donor-specific antibody development, increased graft rejection rates and poor long-term outcome after kidney transplantation. In addition to increased potential for poor graft outcomes, these fluctuations and frequent dose adjustments are confusing and burdensome for patients, add to costs via medication expenses and need for lab checks, and consume the limited resources of transplant centers.
Similarly, non-adherence with immunosuppression medications is common and also linked to poor graft outcomes in kidney transplant patients.
High tacrolimus IPV can be a marker of medication non-adherence. The presence of medication non-adherence could be due to multiple factors such as forgetfulness to take the medication or remembering the correct dose, misunderstanding or miscommunication due to language barrier or logistical issues. High tacrolimus IPV could also be due to difficulty in taking medication every 12 hours, variation in bioavailability of different generic tacrolimus formulations or drug interactions. Considering the IPV of Tacrolimus level, patients and their families often have difficulty managing medications, especially during frequent changes in medication doses. This problem is more prevalent for older patients, who are often on multiple medications and for whom side effects and drug-drug interactions may lead to more harm. Once daily tacrolimus has had mixed results in reducing tacrolimus IPV. Very few studies have been done till now to measure the IPV among patients who received twice daily IR-Tac and converted to once daily Envarsus-XR. These studies were able to show significant reduction in IPV among patients who had high IPV prior to conversion. It is also noteworthy as compared to Astragraf, Envarsus XR has a more favorable pharmacokinetic profile. Envarsus XR uses Melt Dose technology to increase bioavailability and allow a more controlled release of the drug. This results in less fluctuation between maximum ("peak") exposure and trough. From a clinical perspective, Envarsus is noninferior in terms of efficacy (composite endpoint, including kidney transplant graft loss, death, biopsy-proven acute rejection and loss to follow-up) when compared to IR-Tac with a similar safety profile.
Digital health technologies have not been studied in regards to tacrolimus IPV but have shown promising results in improving medication adherence, including in kidney transplant population. TransMedAxTM application; a proposed digital health platform that will be developed to be used in this study. It will utilize dynamic QR code based technology customized to each individual patient, to improve medication adherence. It is especially geared towards patient populations who have frequent changes in medication dosages and have limited English language proficiency. A brief description of TransMedAxTM workflow is as follows:
- Patients will be asked to bring their medication bottle/pill box to the clinic. A QR code unique to the patient will be printed from TransMedAxTM website and attached to medication bottle. TransMedAxTM app will be downloaded on patient's phone.
- Research staff will input tacrolimus medication and dose into the patient's TransMedAxTM application account. The TransMedAxTM verbal instructions will be automatically translated into the patient's preferred language (English, Spanish, Haitian/Creole, or Mandarin).
When this QR code is scanned by the patient using their smartphone camera, it will provide verbal instructions on Tacrolimus dosage and also display the time of the dose on patient's phone. The TransMedAxTM application installed on patient's phone home screen will allow patient to access this information at one-tap and send reminders when the tacrolimus is due. This application will also be used to monitor patient adherence using brief questionnaire.
Many patients and clinicians hope technology will help improve safety, but technology may increase errors if not properly implemented.
Our project will specifically focus on transplant patients in their home/outpatient setting, and addresses language barrier for communication, coordination, and information for these patients. Our focus is on improving patient self-management of tacrolimus medication and informed partnership with clinicians to improve safety.
If successful, our work will have the following impact:
- Provide patients/families, and providers with a readily available tool to manage Tacrolimus doses.
- Improve adherence to the immunosuppressive therapy at appropriate doses prescribed by physician on timely manner.
- This measures will reduce the rate of acute rejection, graft loss and drug side effects and hence the hospitalization.
- Conditions
- Medication Adherence, Renal Transplant
- Being tested
- Conversion to Envarsus-XR and use of smart phone app, TransMedAx, Convert to Envarsus XR once daily
- Keywords
- QR code technology, Envarsus-XR, Tacrolimus trough level, Digital health technology
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversion to Envarsus-XR and use of smart phone app, TransMedAxCombination product
Convert to tacrolimus extended release (Envarsus XR) prescribed dose every 24 hours used in combination with the smart phone application, TransMedAx.
Patients in this arm will be trained to use the app along with conversion to Envarsus-XR. Once patient scan the code on medicine bottle and the app will remind them about the time and dose of the medication in their native language.
Convert to Envarsus XR once dailyDrug
Convert from tacrolimus immediate release to tacrolimus extended release (Envarsus XR) prescribed dose every 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Remain on IR-Tac prescribed doses every 12 hours | No intervention | Patient will remain in Tacrolimus IR-Tac Arm and will complete medication adherence questionnaire monthly. They will not receive any notifications from TransMedAx application. Research staff and PI will collect their Tacrolimus Trough levels and change in tacrolimus dose levels during their routine follow up. |
| Convert to Envarsus XR once daily | Active comparator | Subjects randomized to this arm will switch from IR-Tac to Envarsus XR and will complete medication adherence questionnaire. However, patients in this group will not receive any notifications from TransMedAx application. Research staff and PI will collect their Tacrolimus trough levels and change in tacrolimus dose during their follow up. Receives: Drug: Convert to Envarsus XR once daily |
| Convert to Envarsus XR once daily combined with TransMedAx app use | Experimental | Subjects randomized to this arm will switch from IR-Tac to Envarsus XR, will receive notification by scanning a QR code through TransMedAx application and will complete medication adherence questionnaire. Research staff and PI will collect their Tacrolimus trough levels and change in tacrolimus dose during their follow up. Receives: Combination Product: Conversion to Envarsus-XR and use of smart phone app, TransMedAx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of tacrolimus dose changes in 12 month period.
How frequent was the dose changes in 12 month follow up post transplant, excluding changes made due to change in therapeutic target.
Measured: 1 year follow up
Secondary outcomes (3)
Change in number of tacrolimus dose adjustments in follow up period compared to 12 months prior to enrolment, excluding changes made due to change in therapeutic target
We will note the change in number of Tacrolimus dose adjustments in follow up period and compared the dose changes 12 months prior to enrollment. We will exclude the changes made due to change in therapeutic target.
Measured: 12 months
Self-reported adherence via monthly questionnaire.
We will monitor the patient compliance with self medications among arms and note frequency of non adherence.
Measured: 12 months
• Variability in tacrolimus trough levels, as checked on routine labs as part of standard care
We will monitor the fluctuations in Tacrolimus Trough levels among patients randomized to different arms and compared their variability with the one in Arm 3
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 Jun 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
Why it stopped: PI left organization and study not adopted by any other staff.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- BIDMC kidney transplant patients currently taking immediate release tacrolimus (IR-Tac) will be screened for enrollment into the trial. Eligible patients will be randomized to one of three treatment arms in a 1:1:1 fashion. We aim to randomize seventy-five (75) patients into one of three treatment arms (1:1:1) as described. Arm 1: Remain on tacrolimus immediate release (IR-Tac) prescribed doses every 12 hours; Arm 2: Convert to tacrolimus extended release (Envarsus XR) prescribed dose every 24 hours; OR Arm 3: Convert to tacrolimus extended release (Envarsus XR) prescribed dose every 24 hours used in combination with the smart phone application, TransMedAxTM.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Veloxis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Nikhil Agrawal, MD, Principal investigator, Beth Israel Deaconess Medical CenterMartha Pavlakis, MD, Study director, Beth Israel Deaconess Medical CenterAmtul Aala, MD, Study chair, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711291
- Sponsor's protocol ID
- 2020P001109
- Status last verified
- Aug 2024
- First submitted
- 13 Jan 2021
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borra LC, Roodnat JI, Kal JA, Mathot RA, Weimar W, van Gelder T. High within-patient variability in the clearance of tacrolimus is a risk factor for poor long-term outcome after kidney transplantation. Nephrol Dial Transplant. 2010 Aug;25(8):2757-63. doi: 10.1093/ndt/gfq096. Epub 2010 Feb 26.
PubMed 20190242Kahan BD, Welsh M, Urbauer DL, Mosheim MB, Beusterien KM, Wood MR, Schoenberg LP, Dicesare J, Katz SM, VAN Buren CT. Low intraindividual variability of cyclosporin A exposure reduces chronic rejection incidence and health care costs. J Am Soc Nephrol. 2000 Jun;11(6):1122-1131. doi: 10.1681/ASN.V1161122.
PubMed 10820177Sapir-Pichhadze R, Wang Y, Famure O, Li Y, Kim SJ. Time-dependent variability in tacrolimus trough blood levels is a risk factor for late kidney transplant failure. Kidney Int. 2014 Jun;85(6):1404-11. doi: 10.1038/ki.2013.465. Epub 2013 Dec 11.
PubMed 24336032Shen CL, Yang AH, Lien TJ, Tarng DC, Yang CY. Tacrolimus Blood Level Fluctuation Predisposes to Coexisting BK Virus Nephropathy and Acute Allograft Rejection. Sci Rep. 2017 May 16;7(1):1986. doi: 10.1038/s41598-017-02140-1.
PubMed 28512328Shuker N, Cadogan M, van Gelder T, Roodnat JI, Kho MM, Weimar W, Hesselink DA. Conversion from twice-daily to once-daily tacrolimus does not reduce intrapatient variability in tacrolimus exposure. Ther Drug Monit. 2015 Apr;37(2):262-9. doi: 10.1097/FTD.0000000000000136.
PubMed 25265255Rostaing L, Bunnapradist S, Grinyo JM, Ciechanowski K, Denny JE, Silva HT Jr, Budde K; Envarsus Study Group. Novel Once-Daily Extended-Release Tacrolimus Versus Twice-Daily Tacrolimus in De Novo Kidney Transplant Recipients: Two-Year Results of Phase 3, Double-Blind, Randomized Trial. Am J Kidney Dis. 2016 Apr;67(4):648-59. doi: 10.1053/j.ajkd.2015.10.024. Epub 2015 Dec 22.
PubMed 26717860Foster BJ, Pai ALH, Zelikovsky N, Amaral S, Bell L, Dharnidharka VR, Hebert D, Holly C, Knauper B, Matsell D, Phan V, Rogers R, Smith JM, Zhao H, Furth SL. A Randomized Trial of a Multicomponent Intervention to Promote Medication Adherence: The Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial (TAKE-IT). Am J Kidney Dis. 2018 Jul;72(1):30-41. doi: 10.1053/j.ajkd.2017.12.012. Epub 2018 Mar 27.
PubMed 29602631Riley-Lawless K. Family-identified barriers to medication reconciliation. J Spec Pediatr Nurs. 2009 Apr;14(2):94-101. doi: 10.1111/j.1744-6155.2009.00182.x.
PubMed 19356203Manias E, Hughes C. Challenges of managing medications for older people at transition points of care. Res Social Adm Pharm. 2015 May-Jun;11(3):442-7. doi: 10.1016/j.sapharm.2014.10.001. Epub 2014 Oct 13.
PubMed 25455760Quintana Y, Fahy D, Crotty B, Jain R, Kaldany E, Gorenberg M, Lipsitz L, Engorn D, Rodriguez J, Orfanos A, Bajracharya A, Henao J, Adra M, Skerry D, Slack WV, Safran C. InfoSAGE: Supporting Elders and Families through Online Family Networks. AMIA Annu Symp Proc. 2018 Dec 5;2018:932-941. eCollection 2018.
PubMed 30815136Quintana Y, Crotty B, Fahy D, Lipsitz L, Davis RB, Safran C. Information sharing across generations and environments (InfoSAGE): study design and methodology protocol. BMC Med Inform Decis Mak. 2018 Nov 20;18(1):105. doi: 10.1186/s12911-018-0697-4.
PubMed 30458840Quintana Y, Gonzalez Martorell EA, Fahy D, Safran C. A Systematic Review on Promoting Adherence to Antiretroviral Therapy in HIV-infected Patients Using Mobile Phone Technology. Appl Clin Inform. 2018 Apr;9(2):450-466. doi: 10.1055/s-0038-1660516. Epub 2018 Jun 20.
PubMed 29925099Wolfstadt JI, Gurwitz JH, Field TS, Lee M, Kalkar S, Wu W, Rochon PA. The effect of computerized physician order entry with clinical decision support on the rates of adverse drug events: a systematic review. J Gen Intern Med. 2008 Apr;23(4):451-8. doi: 10.1007/s11606-008-0504-5.
PubMed 18373144Langone A, Steinberg SM, Gedaly R, Chan LK, Shah T, Sethi KD, Nigro V, Morgan JC; STRATO Investigators. Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO (STRATO): an open-label, multicenter, prospective phase 3b study. Clin Transplant. 2015 Sep;29(9):796-805. doi: 10.1111/ctr.12581. Epub 2015 Aug 6.
PubMed 26113208
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Envarsus XR and Digital Health Technology in Reducing Tacrolimus Fluctuation and Frequency of Dose Changes
- ClinicalTrials.gov ID
- NCT04711291
- Acronym / sponsor ID
- 2020P001109
- Conditions
- Medication Adherence, Renal Transplant
- Keywords
- QR code technology, Envarsus-XR, Tacrolimus trough level, Digital health technology
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left organization and study not adopted by any other staff.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Veloxis Pharmaceuticals
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 15 Jan 2021 (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.
Tacrolimus is an immunosuppressive agent prescribed to prevent organ rejection in post transplant patients, in combination with other immunosuppressants. In post-kidney transplant patients, tacrolimus blood trough(peak) level must be monitored frequently, and dose adjustments must be made as necessary to keep trough level within a very narrow target range.
High tacrolimus intra-patient variability(IPV) can be a marker of medication non-adherence. The presence of medication non-adherence could be due to multiple factors e.g. Forgetfulness, misunderstanding or miscommunication due to language barrier etc. Our hypothesis is using QR code technology along with extended release Tacrolimus medication will reduce tacrolimus IPV fluctuation.
Detailed description
Tacrolimus is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants. Envarsus XR (extended release tacrolimus) is a long acting form of tacrolimus that is prescribed as a single dose per day (every 24 hours) rather than immediate release tacrolimus (IR-Tac) which is prescribed as a two doses per day (every 12 hours).
In post-kidney transplant patients, tacrolimus blood trough level must be monitored frequently, and dose adjustments must be made as necessary to keep trough level within a very narrow therapeutic range. High intra-patient variability (IPV) has also been reported to promote donor-specific antibody development, increased graft rejection rates and poor long-term outcome after kidney transplantation. In addition to increased potential for poor graft outcomes, these fluctuations and frequent dose adjustments are confusing and burdensome for patients, add to costs via medication expenses and need for lab checks, and consume the limited resources of transplant centers.
Similarly, non-adherence with immunosuppression medications is common and also linked to poor graft outcomes in kidney transplant patients.
High tacrolimus IPV can be a marker of medication non-adherence. The presence of medication non-adherence could be due to multiple factors such as forgetfulness to take the medication or remembering the correct dose, misunderstanding or miscommunication due to language barrier or logistical issues. High tacrolimus IPV could also be due to difficulty in taking medication every 12 hours, variation in bioavailability of different generic tacrolimus formulations or drug interactions. Considering the IPV of Tacrolimus level, patients and their families often have difficulty managing medications, especially during frequent changes in medication doses. This problem is more prevalent for older patients, who are often on multiple medications and for whom side effects and drug-drug interactions may lead to more harm. Once daily tacrolimus has had mixed results in reducing tacrolimus IPV. Very few studies have been done till now to measure the IPV among patients who received twice daily IR-Tac and converted to once daily Envarsus-XR. These studies were able to show significant reduction in IPV among patients who had high IPV prior to conversion. It is also noteworthy as compared to Astragraf, Envarsus XR has a more favorable pharmacokinetic profile. Envarsus XR uses Melt Dose technology to increase bioavailability and allow a more controlled release of the drug. This results in less fluctuation between maximum ("peak") exposure and trough. From a clinical perspective, Envarsus is noninferior in terms of efficacy (composite endpoint, including kidney transplant graft loss, death, biopsy-proven acute rejection and loss to follow-up) when compared to IR-Tac with a similar safety profile.
Digital health technologies have not been studied in regards to tacrolimus IPV but have shown promising results in improving medication adherence, including in kidney transplant population. TransMedAxTM application; a proposed digital health platform that will be developed to be used in this study. It will utilize dynamic QR code based technology customized to each individual patient, to improve medication adherence. It is especially geared towards patient populations who have frequent changes in medication dosages and have limited English language proficiency. A brief description of TransMedAxTM workflow is as follows:
- Patients will be asked to bring their medication bottle/pill box to the clinic. A QR code unique to the patient will be printed from TransMedAxTM website and attached to medication bottle. TransMedAxTM app will be downloaded on patient's phone.
- Research staff will input tacrolimus medication and dose into the patient's TransMedAxTM application account. The TransMedAxTM verbal instructions will be automatically translated into the patient's preferred language (English, Spanish, Haitian/Creole, or Mandarin).
When this QR code is scanned by the patient using their smartphone camera, it will provide verbal instructions on Tacrolimus dosage and also display the time of the dose on patient's phone. The TransMedAxTM application installed on patient's phone home screen will allow patient to access this information at one-tap and send reminders when the tacrolimus is due. This application will also be used to monitor patient adherence using brief questionnaire.
Many patients and clinicians hope technology will help improve safety, but technology may increase errors if not properly implemented.
Our project will specifically focus on transplant patients in their home/outpatient setting, and addresses language barrier for communication, coordination, and information for these patients. Our focus is on improving patient self-management of tacrolimus medication and informed partnership with clinicians to improve safety.
If successful, our work will have the following impact:
- Provide patients/families, and providers with a readily available tool to manage Tacrolimus doses.
- Improve adherence to the immunosuppressive therapy at appropriate doses prescribed by physician on timely manner.
- This measures will reduce the rate of acute rejection, graft loss and drug side effects and hence the hospitalization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- BIDMC kidney transplant patients currently taking immediate release tacrolimus (IR-Tac) will be screened for enrollment into the trial. Eligible patients will be randomized to one of three treatment arms in a 1:1:1 fashion. We aim to randomize seventy-five (75) patients into one of three treatment arms (1:1:1) as described. Arm 1: Remain on tacrolimus immediate release (IR-Tac) prescribed doses every 12 hours; Arm 2: Convert to tacrolimus extended release (Envarsus XR) prescribed dose every 24 hours; OR Arm 3: Convert to tacrolimus extended release (Envarsus XR) prescribed dose every 24 hours used in combination with the smart phone application, TransMedAxTM.
| Arm | Type | Receives |
|---|---|---|
| Remain on IR-Tac prescribed doses every 12 hours | No intervention | –Patient will remain in Tacrolimus IR-Tac Arm and will complete medication adherence questionnaire monthly. They will not receive any notifications from TransMedAx application. Research staff and PI will collect their Tacrolimus Trough levels and change in tacrolimus dose levels during their routine follow up. |
| Convert to Envarsus XR once daily | Active comparator | Drug: Convert to Envarsus XR once dailySubjects randomized to this arm will switch from IR-Tac to Envarsus XR and will complete medication adherence questionnaire. However, patients in this group will not receive any notifications from TransMedAx application. Research staff and PI will collect their Tacrolimus trough levels and change in tacrolimus dose during their follow up. |
| Convert to Envarsus XR once daily combined with TransMedAx app use | Experimental | Combination Product: Conversion to Envarsus-XR and use of smart phone app, TransMedAxSubjects randomized to this arm will switch from IR-Tac to Envarsus XR, will receive notification by scanning a QR code through TransMedAx application and will complete medication adherence questionnaire. Research staff and PI will collect their Tacrolimus trough levels and change in tacrolimus dose during their follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BIDMC adult kidney transplant recipient more than 2 years post transplant
- On tacrolimus IR regimen
- Estimated glomerular filtration rate (eGFR) >45
- Tacrolimus dose adjustments 2 or more times in past 12 months
- Own and able to use a smart phone.
Key exclusion criteria (3 listed)
- Prisoners
- Patients with primary language other than English, Spanish, Haitian/Creole, Mandarin
- Patients who can't swallow whole tablets or capsules.
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 |
|---|---|---|
| Conversion to Envarsus-XR and use of smart phone app, TransMedAxConvert to tacrolimus extended release (Envarsus XR) prescribed dose every 24 hours used in combination with the smart phone application, TransMedAx. Patients in this arm will be trained to use the app along with conversion to Envarsus-XR. Once patient scan the code on medicine bottle and the app will remind them about the time and dose of the medication in their native language. | Combination product | Convert to Envarsus XR once daily combined with TransMedAx app use |
| Convert to Envarsus XR once dailyConvert from tacrolimus immediate release to tacrolimus extended release (Envarsus XR) prescribed dose every 24 hours | Drug | Convert to Envarsus XR once daily |
Primary outcome
Number of tacrolimus dose changes in 12 month period.
Time frame: 1 year follow up
How frequent was the dose changes in 12 month follow up post transplant, excluding changes made due to change in therapeutic target.
3 secondary outcomes
Change in number of tacrolimus dose adjustments in follow up period compared to 12 months prior to enrolment, excluding changes made due to change in therapeutic target
Time frame: 12 months
Self-reported adherence via monthly questionnaire.
Time frame: 12 months
• Variability in tacrolimus trough levels, as checked on routine labs as part of standard care
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 20190242Borra LC, Roodnat JI, Kal JA, Mathot RA, Weimar W, van Gelder T. High within-patient variability in the clearance of tacrolimus is a risk factor for poor long-term outcome after kidney transplantation. Nephrol Dial Transplant. 2010 Aug;25(8):2757-63. doi: 10.1093/ndt/gfq096. Epub 2010 Feb 26.
- Background: PubMed 10820177Kahan BD, Welsh M, Urbauer DL, Mosheim MB, Beusterien KM, Wood MR, Schoenberg LP, Dicesare J, Katz SM, VAN Buren CT. Low intraindividual variability of cyclosporin A exposure reduces chronic rejection incidence and health care costs. J Am Soc Nephrol. 2000 Jun;11(6):1122-1131. doi: 10.1681/ASN.V1161122.
- Background: PubMed 24336032Sapir-Pichhadze R, Wang Y, Famure O, Li Y, Kim SJ. Time-dependent variability in tacrolimus trough blood levels is a risk factor for late kidney transplant failure. Kidney Int. 2014 Jun;85(6):1404-11. doi: 10.1038/ki.2013.465. Epub 2013 Dec 11.
- Background: PubMed 28512328Shen CL, Yang AH, Lien TJ, Tarng DC, Yang CY. Tacrolimus Blood Level Fluctuation Predisposes to Coexisting BK Virus Nephropathy and Acute Allograft Rejection. Sci Rep. 2017 May 16;7(1):1986. doi: 10.1038/s41598-017-02140-1.
- Background: PubMed 25265255Shuker N, Cadogan M, van Gelder T, Roodnat JI, Kho MM, Weimar W, Hesselink DA. Conversion from twice-daily to once-daily tacrolimus does not reduce intrapatient variability in tacrolimus exposure. Ther Drug Monit. 2015 Apr;37(2):262-9. doi: 10.1097/FTD.0000000000000136.
- Background: PubMed 26717860Rostaing L, Bunnapradist S, Grinyo JM, Ciechanowski K, Denny JE, Silva HT Jr, Budde K; Envarsus Study Group. Novel Once-Daily Extended-Release Tacrolimus Versus Twice-Daily Tacrolimus in De Novo Kidney Transplant Recipients: Two-Year Results of Phase 3, Double-Blind, Randomized Trial. Am J Kidney Dis. 2016 Apr;67(4):648-59. doi: 10.1053/j.ajkd.2015.10.024. Epub 2015 Dec 22.
- Background: PubMed 29602631Foster BJ, Pai ALH, Zelikovsky N, Amaral S, Bell L, Dharnidharka VR, Hebert D, Holly C, Knauper B, Matsell D, Phan V, Rogers R, Smith JM, Zhao H, Furth SL. A Randomized Trial of a Multicomponent Intervention to Promote Medication Adherence: The Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial (TAKE-IT). Am J Kidney Dis. 2018 Jul;72(1):30-41. doi: 10.1053/j.ajkd.2017.12.012. Epub 2018 Mar 27.
- Background: PubMed 19356203Riley-Lawless K. Family-identified barriers to medication reconciliation. J Spec Pediatr Nurs. 2009 Apr;14(2):94-101. doi: 10.1111/j.1744-6155.2009.00182.x.
- Background: PubMed 25455760Manias E, Hughes C. Challenges of managing medications for older people at transition points of care. Res Social Adm Pharm. 2015 May-Jun;11(3):442-7. doi: 10.1016/j.sapharm.2014.10.001. Epub 2014 Oct 13.
- Background: PubMed 30815136Quintana Y, Fahy D, Crotty B, Jain R, Kaldany E, Gorenberg M, Lipsitz L, Engorn D, Rodriguez J, Orfanos A, Bajracharya A, Henao J, Adra M, Skerry D, Slack WV, Safran C. InfoSAGE: Supporting Elders and Families through Online Family Networks. AMIA Annu Symp Proc. 2018 Dec 5;2018:932-941. eCollection 2018.
- Background: PubMed 30458840Quintana Y, Crotty B, Fahy D, Lipsitz L, Davis RB, Safran C. Information sharing across generations and environments (InfoSAGE): study design and methodology protocol. BMC Med Inform Decis Mak. 2018 Nov 20;18(1):105. doi: 10.1186/s12911-018-0697-4.
- Background: PubMed 29925099Quintana Y, Gonzalez Martorell EA, Fahy D, Safran C. A Systematic Review on Promoting Adherence to Antiretroviral Therapy in HIV-infected Patients Using Mobile Phone Technology. Appl Clin Inform. 2018 Apr;9(2):450-466. doi: 10.1055/s-0038-1660516. Epub 2018 Jun 20.
- 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.
Nikhil Agrawal, MD principal investigator
Beth Israel Deaconess Medical Center
Martha Pavlakis, MD study director
Beth Israel Deaconess Medical Center
Amtul Aala, MD study chair
Beth Israel Deaconess Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Conversion to Envarsus-XR and use of smart phone app, TransMedAx and Convert to Envarsus XR once daily in people with Medication Adherence and Renal Transplant, run by Beth Israel Deaconess Medical Center.
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 6 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: withdrawn, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Number of tacrolimus dose changes in 12 month period. (time frame: 1 year follow up). 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 NCT04711291, which also lists 14 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 9 Aug 2024.