Efficacy of Envarsus XR and Digital Health Technology in Reducing Tacrolimus Fluctuation and Frequency of Dose Changes

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 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.

Timeline

Start

2017-06-01

Primary completion

2022-12-31

Completion

2023-07-01

Publications

• Background 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.
• Background Kahan 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 Sapir-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 Shen 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 Shuker 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 Rostaing 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 Foster 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 Riley-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 Manias 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 Quintana 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 Quintana 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 Quintana 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.
• Background Wolfstadt 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.
• Background Langone 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.

Drugs

Indications

No indication recorded.