New formulations of tacrolimus and prevention of acute and chronic rejections in adult kidney-transplant recipients

References

• Ojo AO, Held PJ, Port FK, et al. Chronic renal failure after transplantation of a non-renal organ. N Engl J Med. 2003 Sep 4;349(10):931–940. ​
   PubMed Web of Science ®Google Scholar
• Opelz G, Döhler B; Collaborative Transplant Study. Influence of immunosuppressive regimens on graft survival and secondary outcomes after kidney transplantation. Transplantation. 2009 Mar 27;87(6):795–802. DOI:10.1097/TP.0b013e318199c1c7
   PubMed Web of Science ®Google Scholar
• Ekberg H, Tedesco-Silva H, Demirbas A, et al. Reduced exposure to calcineurin inhibitors in renal transplantation. N Engl J Med. 2007 Dec 20;357(25):2562–2575.
   PubMed Web of Science ®Google Scholar
• Ekberg H, Bernasconi C, Tedesco-Silva H, et al. Calcineurin inhibitor minimization in the Symphony study: observational results 3 years after transplantation. Am J Transplant. 2009 Aug;9(8):1876–1885. DOI:10.1111/j.1600-6143.2009.02726.x
   PubMed Web of Science ®Google Scholar
• Hricik DE, Formica RN, Nickerson P, et al. Adverse outcomes of tacrolimus withdrawal in immune-quiescent kidney transplant recipients. J Am Soc Nephrol. 2015 Dec;26(12):3114–3122. DOI:10.1681/ASN.2014121234
   PubMed Web of Science ®Google Scholar
• Dugast E, Soulillou J-P, Foucher Y, et al. Failure of calcineurin inhibitor (tacrolimus) weaning randomized trial in long-term stable kidney transplant recipients. Am J Transplant. 2016 Nov;16(11):3255–3261. DOI:10.1111/ajt.13946
   PubMed Web of Science ®Google Scholar
• Gatault P, Kamar N, Büchler M, et al. Reduction of extended-release tacrolimus dose in low immunological risk kidney transplant recipients increases risk of rejection and appearance of DSA – a randomized study. Am J Transplant. 2016 Nov 9. DOI:10.1111/ajt.14109
   Web of Science ®Google Scholar
• Shuker N, Shuker L, van Rosmalen J, et al. A high intrapatient variability in tacrolimus exposure is associated with poor long-term outcome of kidney transplantation. Transpl Int. 2016 Nov;29(11):1158–1167. DOI:10.1111/tri.12798
   PubMed Web of Science ®Google Scholar
• Staatz CE, Tett SE. Clinical pharmacokinetics of once-daily tacrolimus in solid-organ transplant patients. Clin Pharmacokinet. 2015 Oct;54(10):993–1025. DOI:10.1007/s40262-015-0282-2
   PubMed Web of Science ®Google Scholar
• Starzl TE, Fung J, Jordan M, et al. Kidney transplantation under FK 506. JAMA. 1990 Jul;264(1):63–67.
   PubMed Web of Science ®Google Scholar
• Malvezzi P, Rostaing L. The safety of calcineurin inhibitors for kidney-transplant patients. Expert Opin Drug Saf. 2015;14(10):1531–1546. DOI:10.1517/14740338.2015.1083974
   PubMed Web of Science ®Google Scholar
• Kuypers DRJ. Immunosuppressive drug monitoring – what to use in clinical practice today to improve renal graft outcome. Transpl Int. 2005 Feb;18(2):140–150.
   PubMed Web of Science ®Google Scholar
• Nankivell BJ, Borrows RJ, Fung CL, et al. The natural history of chronic allograft nephropathy. N Engl J Med. 2003 Dec;349(24):2326–2333.
   PubMedGoogle Scholar
• Snanoudj R, Royal V, Elie C, et al. Specificity of histological markers of long-term CNI nephrotoxicity in kidney-transplant recipients under low-dose cyclosporine therapy. Am J Transplant. 2011;11(12):2635–2646. DOI:10.1111/j.1600-6143.2011.03718.x
   PubMed Web of Science ®Google Scholar
• Nankivell BJ, PʼNg CH, OʼConnell PJ, et al. Calcineurin inhibitor nephrotoxicity through the lens of longitudinal histology: comparison of cyclosporine and tacrolimus eras. Transplantation. 2016;100(8):1723–1731. DOI:10.1097/TP.0000000000001243
   PubMed Web of Science ®Google Scholar
• Gaston RS. Chronic calcineurin inhibitor nephrotoxicity: reflections on an evolving paradigm. Clin J Am Soc Nephrol. 2009;4(12):2029–2034. DOI:10.2215/CJN.03820609
   PubMed Web of Science ®Google Scholar
• Naesens M, Lerut E. Calcineurin inhibitor nephrotoxicity in the era of antibody-mediated rejection. Transplantation. 2016;100(8):1599–1600. DOI:10.1097/TP.0000000000001244
   PubMed Web of Science ®Google Scholar
• El-Zoghby ZM, Stegall MD, Lager DJ. Identifying specific causes of kidney allograft loss. Am J Transplant. 2009 Mar;9(3):527–535. DOI:10.1111/j.1600-6143.2008.02519.x
   PubMed Web of Science ®Google Scholar
• Racusen LC, Solez K, Colvin RB, et al. The Banff 97 working classification of renal allograft pathology. Kidney Int. 1999 Feb;55(2):713–723.
   PubMed Web of Science ®Google Scholar
• Mengel M, Sis B, Haas M, et al. Banff 2011 meeting report: new concepts in antibody-mediated rejection. Am J Transplant. 2012;12(3):563–570. DOI:10.1111/j.1600-6143.2011.03926.x
   PubMed Web of Science ®Google Scholar
• Haas M, Sis B, Racusen LC, et al. Banff 2013 meeting report: inclusion of c4d-negative antibody-mediated rejection and antibody-associated arterial lesions. Am J Transplant. 2014 Feb;14(2):272–283. DOI:10.1111/ajt.12590
   PubMed Web of Science ®Google Scholar
• Haas M. An updated Banff schema for diagnosis of antibody-mediated rejection in renal allografts. Curr Opin Organ Transplant. 2014;19(3):315–322. DOI:10.1097/MOT.0000000000000072
   PubMed Web of Science ®Google Scholar
• Loupy A, Haas M, Solez K, et al. The Banff 2015 kidney meeting report: current challenges in rejection classification and prospects for adopting molecular pathology. Am J Transplant. 2016 Nov 10. DOI:10.1111/ajt.14107
   Web of Science ®Google Scholar
• Colvin RB. Pathology of chronic humoral rejection. Contrib Nephrol. 2009;162:75–86.
   PubMed Web of Science ®Google Scholar
• Platt JL. Antibodies in transplantation. Discov Med. 2010;10(51):125–133.
   PubMed Web of Science ®Google Scholar
• Gaston RS, Cecka JM, Kasiske BL, et al. Evidence for antibody-mediated injury as a major determinant of late kidney allograft failure. Transplantation. 2010;90(1):68–74.
   PubMed Web of Science ®Google Scholar
• Farkash EA, Colvin RB. Pathology: diagnostic challenges in chronic antibody-mediated rejection. Nat Rev Nephrol. 2012;8(5):255–257. DOI:10.1038/nrneph.2012.61
   PubMed Web of Science ®Google Scholar
• Everly MJ. Summarizing the use of donor specific anti-HLA antibody monitoring in transplant patients. Clin Transpl. 2011;333–336. ​
   PubMedGoogle Scholar
• Everly MJ, Rebellato LM, Haisch CE, et al. Incidence and impact of de novo donor-specific alloantibody in primary renal allografts. Transplantation. 2013;95(3):410–417. DOI:10.1097/TP.0b013e31827d62e3
   PubMed Web of Science ®Google Scholar
• Sellarés J, de Freitas DG, Mengel M, et al. Understanding the causes of kidney transplant failure: the dominant role of antibody-mediated rejection and nonadherence. Am J Transplant. 2012;12(2):388–399. DOI:10.1111/j.1600-6143.2011.03840.x
   PubMed Web of Science ®Google Scholar
• Wiebe C, Gibson IW, Blydt-Hansen TD, et al. Evolution and clinical pathologic correlations of de novo donor-specific HLA antibody post kidney transplant. Am J Transplant. 2012;12(5):1157–1167. DOI:10.1111/j.1600-6143.2012.04013.x
   PubMed Web of Science ®Google Scholar
• Wiebe C, Nickerson P. Posttransplant monitoring of de novo human leukocyte antigen donor-specific antibodies in kidney transplantation. Curr Opin Organ Transplant. 2013;18(4):470–477. DOI:10.1097/MOT.0b013e3283626149
   PubMed Web of Science ®Google Scholar
• Shuker N, van Gelder T, Hesselink DA. Intra-patient variability in tacrolimus exposure: causes, consequences for clinical management. Transplant Rev (Orlando). 2015;29(2):78–84. DOI:10.1016/j.trre.2015.01.002
   PubMedGoogle Scholar
• Borra LC, Roodnat JI, Kal JA, et al. 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;25(8):2757–2763. DOI:10.1093/ndt/gfq096
   PubMed Web of Science ®Google Scholar
• Sapir-Pichhadze R, Wang Y, Famure O, et al. Time-dependent variability in tacrolimus trough blood levels is a risk factor for late kidney transplant failure. Kidney Int. 2014;85(6):1404–1411. DOI:10.1038/ki.2013.465
   PubMed Web of Science ®Google Scholar
• Benkali K, Rostaing L, Premaud A, et al. Population pharmacokinetics and Bayesian estimation of tacrolimus exposure in renal transplant recipients on a new once-daily formulation. Clin Pharmacokinet. 2010 Oct;49(10):683–692. DOI:10.2165/11535950-000000000-00000
   PubMed Web of Science ®Google Scholar
• Wlodarczyk Z, Squifflet J-P, Ostrowski M, et al. Pharmacokinetics for once- versus twice-daily tacrolimus formulations in de novo kidney transplantation: a randomized, open-label trial. Am J Transplant. 2009 Nov;9(11):2505–2513. DOI:10.1111/j.1600-6143.2009.02794.x
   PubMed Web of Science ®Google Scholar
• Krämer BK, Charpentier B, Bäckman L, et al. Tacrolimus once daily (ADVAGRAF®) versus twice daily (PROGRAF®) in de novo renal transplantation: a randomized phase III study. Am J Transplant. 2010 Dec;10(12):2632–2643. DOI:10.1111/j.1600-6143.2010.03256.x
   PubMed Web of Science ®Google Scholar
• Silva HT Jr, Yang HC, Meier-Kriesche H-U, et al. Long-term follow-up of a phase III clinical trial comparing tacrolimus extended-release/MMF, tacrolimus/MMF, and cyclosporine/MMF in de novo kidney transplant recipients. Transplantation. 2014 Mar 27;97(6):636–641. DOI:10.1097/01.TP.0000437669.93963.8E
   PubMed Web of Science ®Google Scholar
• Silva HT, Yang HC, Abouljoud M, et al. One-year results with extended-release tacrolimus/MMF, tacrolimus/MMF and cyclosporine/MMF in de novo kidney transplant recipients. Am J Transplant. 2007 Mar;7(3):595–608. Erratum in: Am J Transplant. 2007 Jun;7(6):1682.
   PubMed Web of Science ®Google Scholar
• Albano L, Banas B, Klempnauer JL, et al. OSAKA trial: a randomized, controlled trial comparing tacrolimus QD and BD in kidney transplantation. Transplant J. 2013;96:897–903.10.1097/TP.0b013e3182a203bd.
   PubMed Web of Science ®Google Scholar
• Kuypers DRJ, Peeters PC, Sennesael JJ, et al. Improved adherence to tacrolimus once-daily formulation in renal recipients: a randomized controlled trial using electronic monitoring. Transplantation. 2013;95:333–340. DOI:10.1097/TP.0b013e3182725532
   PubMed Web of Science ®Google Scholar
• Adam R, Karam V, Delvart V, et al. Improved survival in liver transplant recipients receiving prolonged-release tacrolimus in the European Liver Transplant Registry. Am J Transplant. 2015 May;15(5):1267–1282. DOI:10.1111/ajt.13171
   PubMed Web of Science ®Google Scholar
• European Agency for the Evaluation of Medicinal Products. Note for guidance on modified release oral and transdermal dosage forms: section II (pharmacokinetic and clinical evaluation). [ cited Jan 2014]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09WC500003126.pdf.
   Google Scholar
• Gaber AO, Alloway RR, Bodziak K, et al. Conversion from twice-daily tacrolimus capsules to once-daily extended-release tacrolimus (LCPT): a phase 2 trial of stable renal transplant recipients. Transplantation. 2013;96(2):191–197. DOI:10.1097/TP.0b013e3182962cc1
   PubMed Web of Science ®Google Scholar
• Budde K, Bunnapradist S, Grinyo JM, et al. Novel once-daily extended-release tacrolimus (LCPT) versus twice-daily tacrolimus in de novo kidney transplants: one-year results of phase III, double-blind, randomized trial. Am J Transplant. 2014;14(12):2796–2806. DOI:10.1111/ajt.12955
   PubMed Web of Science ®Google Scholar
• Rostaing R, Bunnapradist S, Grinyó JM, et al. 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;67(4):648. DOI:10.1053/j.ajkd.2015.10.024
   PubMed Web of Science ®Google Scholar
• Langone A, Steinberg SM, Gedaly R, et al. Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO (STRATO): an open-label, multicenter, prospective phase 3b study. Clin Transplant. 2015;29(9):796–805. DOI:10.1111/ctr.12581
   PubMed Web of Science ®Google Scholar
• Tremblay S, Nigro V, Weinberg J, et al. A steady-state head-to-head pharmacokinetic comparison of all FK-506 (Tacrolimus) formulations (ASTCOFF): an open-label, prospective, randomized, two-arm, three-period crossover study. Am J Transplant. 2016 Jun 24. DOI:10.1111/ajt.13935
   Web of Science ®Google Scholar
• Tsipotis E, Gupta NR, Raman G, et al. Bioavailability, efficacy and safety of generic immunosuppressive drugs for kidney transplantation: a systematic review and meta-analysis. Am J Nephrol. 2016;44(3):206–218. DOI:10.1159/000449020
   PubMed Web of Science ®Google Scholar
• Hauch A, John M, Smith A, et al. Generics: are all immunosuppression agents created equally? Surgery. 2015 Oct;158(4):1049–1054; discussion 1054–1055. DOI:10.1016/j.surg.2015.05.024
   PubMed Web of Science ®Google Scholar
• Melilli E, Crespo E, Sandoval D, et al. De novo use of a generic formulation of tacrolimus versus reference tacrolimus in kidney transplantation: evaluation of the clinical results, histology in protocol biopsies, and immunological monitoring. Transpl Int. 2015 Nov;28(11):1283–1290. DOI:10.1111/tri.12626
   PubMed Web of Science ®Google Scholar
• Son SY, Jang HR, Lee JE, et al. Comparison of the long-term efficacy and safety of generic Tacrobell with original tacrolimus (Prograf) in kidney transplant recipients. Drug Des Devel Ther. 2017 Jan 12; 11: 203–210. eCollection 2017. DOI:10.2147/DDDT.S118154
   PubMed Web of Science ®Google Scholar
• Kim JM, Kwon CH, Joh J-W, et al. Differences in peripheral blood lymphocytes between brand-name and generic tacrolimus treated in stable liver transplant recipients. Med Princ Pract. 2017 Jan 9. [Epub ahead of print]. DOI:10.1159/000455861
   Web of Science ®Google Scholar
• Shuker N, Bouamar R, van Schaik RH, et al. A randomized controlled trial comparing the efficacy of Cyp3a5 genotype-based with body-weight-based tacrolimus dosing after living donor kidney transplantation. Am J Transplant. 2016 Jul;16(7):2085–2096. DOI:10.1111/ajt.13691
   PubMed Web of Science ®Google Scholar
• Pallet N, Etienne I, Buchler M, et al. Long-term clinical impact of adaptation of initial tacrolimus dosing to CYP3A5 genotype. Am J Transplant. 2016 Sep;16(9):2670–2675. DOI:10.1111/ajt.13788
   PubMed Web of Science ®Google Scholar
• Piao SG, Bae SK, Lim SW, et al. Drug interaction between cyclosporine and mTOR inhibitors in experimental model of chronic cyclosporine nephrotoxicity and pancreatic islet dysfunction. Transplantation. 2012 Feb 27;93(4):383–389. DOI:10.1097/TP.0b013e3182421604
   PubMed Web of Science ®Google Scholar
• Piao SG, Lim SW, Doh KC, et al. Combined treatment of tacrolimus and everolimus increases oxidative stress by pharmacological interactions. Transplantation. 2014 Jul 15;98(1):22–28. DOI:10.1097/TP.0000000000000146
   PubMed Web of Science ®Google Scholar
• Langer RM, Hené R, Vitko S, et al. Everolimus plus early tacrolimus minimization: a phase III, randomized, open-label, multicentre trial in renal transplantation. Transpl Int. 2012 May;25(5):592–602. DOI:10.1111/j.1432-2277.2012.01465.x
   PubMed Web of Science ®Google Scholar
• Shihab F, Qazi Y, Mulgaonkar S, et al. Association of clinical events with everolimus exposure in kidney transplant patients receiving low doses of tacrolimus. Am J Transplant. 2017 Jan 31. [Epub ahead of print]. DOI:10.1111/ajt.14215
   Google Scholar