Envarsus XL Immunosuppression Following Liver Transplantation

Summary

The standard immunosuppressive regimen for liver transplantation includes twice daily tacrolimus (Prograf). In other transplantation models, there are potential benefits to extended release formulations as lower peak concentrations are thought to have lower rates of nephrotoxicity. Additionally, compliance with once daily medications is felt to be easier than twice daily medications. Our aim is to look at our prospective liver transplant group and see if once daily tacrolimus (Envarsus XR) results in improved renal function as well as improved health care quality of life.

Timeline

Start

2019-04-01

Primary completion

2020-12-31

Completion

2020-12-31

Publications

• Background Kadam P, Bhalerao S. Sample size calculation. Int J Ayurveda Res. 2010 Jan;1(1):55-7. doi: 10.4103/0974-7788.59946. No abstract available.
• Results Abdelmalek MF, Humar A, Stickel F, Andreone P, Pascher A, Barroso E, Neff GW, Ranjan D, Toselli LT, Gane EJ, Scarola J, Alberts RG, Maller ES, Lo CM; Sirolimus Liver Conversion Trial Study Group. Sirolimus conversion regimen versus continued calcineurin inhibitors in liver allograft recipients: a randomized trial. Am J Transplant. 2012 Mar;12(3):694-705. doi: 10.1111/j.1600-6143.2011.03919.x. Epub 2012 Jan 10.
• Results Backman L, Nicar M, Levy M, Distant D, Eisenstein C, Renard T, Goldstein R, Husberg B, Gonwa TA, Klintmalm G. FK506 trough levels in whole blood and plasma in liver transplant recipients. Correlation with clinical events and side effects. Transplantation. 1994 Feb 27;57(4):519-25.
• Results Kong Y, Wang D, Shang Y, Liang W, Ling X, Guo Z, He X. Calcineurin-inhibitor minimization in liver transplant patients with calcineurin-inhibitor-related renal dysfunction: a meta-analysis. PLoS One. 2011;6(9):e24387. doi: 10.1371/journal.pone.0024387. Epub 2011 Sep 9.
• Results 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.
• Results Yoo MC, Vanatta JM, Modanlou KA, Campos L, Nezakatgoo N, Nair S, Eason JD. Steroid-free Liver Transplantation Using Rabbit Antithymocyte Globulin Induction in 500 Consecutive Patients. Transplantation. 2015 Jun;99(6):1231-5. doi: 10.1097/TP.0000000000000477.
• Results Garnock-Jones KP. Tacrolimus prolonged release (Envarsus(R)): a review of its use in kidney and liver transplant recipients. Drugs. 2015 Feb;75(3):309-20. doi: 10.1007/s40265-015-0349-2.
• Results Niel OR, Berthoux F, Albano L, Dahan P, Aoudia R, Gugenheim J, Cassuto E. Long-term glomerular filtration rate in liver allograft recipients according to the type of calcineurin inhibitors. Transplant Proc. 2009 Oct;41(8):3329-32. doi: 10.1016/j.transproceed.2009.09.034.

Drugs

Indications

No indication recorded.