438
Views
6
CrossRef citations to date
0
Altmetric
Review

An update on chemical pharmacotherapy options for the prevention of kidney transplant rejection with a focus on costimulation blockade

ORCID Icon, , , , , & show all
Pages 799-807 | Received 10 Mar 2017, Accepted 24 Apr 2017, Published online: 09 May 2017

References

  • Wolfe RA, Ashby VB, Milford EL, et al. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med. 1999;341:1725–1730. Epub 1999/12/02.
  • Borel JF, Feurer C, Gubler HU, et al. Biological effects of cyclosporin A: a new antilymphocytic agent. Agents Actions. 1976;6:468–475. Epub 1976/07/01.
  • Canadian Multicentre Transplant Study Group. A randomized clinical trial of cyclosporine in cadaveric renal transplantation. N Engl J Med. 1983;309:809–815. Epub 1983/10/06.
  • Meier-Kriesche HU, Schold JD, Srinivas TR, et al. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant. 2004;4:378–383. Epub 2004/02/14.
  • Ekberg H, Tedesco-Silva H, Demirbas A, et al. Reduced exposure to calcineurin inhibitors in renal transplantation. N Engl J Med. 2007;357:2562–2575.
  • 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;9:1876–1885. Epub 2009/07/01.
  • Vincenti F, Ramos E, Brattstrom C, et al. Multicenter trial exploring calcineurin inhibitors avoidance in renal transplantation. Transplantation. 2001;71:1282–1287.
  • Calne RY, White DJ, Thiru S, et al. Cyclosporin A in patients receiving renal allografts from cadaver donors. Lancet. 1978;2:1323–1327. Epub 1978/12/23.
  • Sanders CE, Julian BA, Gaston RS, et al. Benefits of continued cyclosporine through an indigent drug program. Am J Kidney Dis. 1996;28:572–577.
  • Curtis JJ. Hypertensinogenic mechanism of the calcineurin inhibitors. Curr Hypertens Rep. 2002;4:377–380.
  • Kobashigawa JA, Kasiske BL. Hyperlipidemia in solid organ transplantation. Transplantation. 1997;63:331–338.
  • Chapman JR. Chronic calcineurin inhibitor nephrotoxicity-lest we forget. Am J Transplant. 2011;11:693–697. Epub 2011/03/31.
  • Hazzan M, Buob D, Labalette M, et al. Assessment of the risk of chronic allograft dysfunction after renal transplantation in a randomized cyclosporine withdrawal trial. Transplantation. 2006;82:657–662.
  • Cibrik D, Silva HT Jr., Vathsala A, et al. Randomized trial of everolimus-facilitated calcineurin inhibitor minimization over 24 months in renal transplantation. Transplantation. 2013;95:933–942. Epub 2013/02/21.
  • Gatault P, Kamar N, Buchler M, et al. Reduction of extended-release tacrolimus dose in low-immunological-risk kidney transplant recipients increases risk of rejection and appearance of donor-specific antibodies: a randomized study. Am J Transplant. 2017;17(5):1370–1379.
  • Hricik DE, Formica RN, Nickerson P, et al.; Clinical Trials in Organ Transplantation C. Adverse outcomes of tacrolimus withdrawal in immune-quiescent kidney transplant recipients. J Am Soc Nephrol. 2015;26:3114–3122.
  • Weir MR, Blahut S, Drachenburg C, et al. Late calcineurin inhibitor withdrawal as a strategy to prevent graft loss in patients with suboptimal kidney transplant function. Am J Nephrol. 2004;24:379–386.
  • Frimat L, Cassuto-Viguier E, Provot F, et al. Long-term impact of cyclosporin reduction with MMF treatment in chronic allograft dysfunction: REFERENECE Study 3-year follow up. J Transplant. 2010;2010. pii: 402750. doi:10.1155/2010/402750. Epub 2010 Jul 28. PMID: 20706667.
  • Sommerer C, Glander P, Arns W, et al. Safety and efficacy of intensified versus standard dosing regimens of enteric-coated mycophenolate sodium in de novo renal transplant patients. Transplantation. 2011;91:779–785.
  • Arns W, Sommerer C, Glander P, et al. A randomized trial of intensified vs. standard dosing for enteric-coated mycophenolate sodium in de novo kidney transplant recipients: results at 1 year. Clin Nephrol. 2013;79:421–431.
  • Sommerer C, Giese T. Nuclear factor of activated t cells-regulated gene expression as predictive biomarker of personal response to calcineurin inhibitors. Ther Drug Monit. 2016;38(Suppl 1):S50–6.
  • Brunet M, Shipkova M, van Gelder T, et al. Barcelona consensus on biomarker-based immunosuppressive drugs management in solid organ transplantation. Ther Drug Monit. 2016;38(Suppl 1):S1–20.
  • Schnuelle P, van der Heide JH, Tegzess A, et al. Open randomized trial comparing early withdrawal of either cyclosporine or mycophenolate mofetil in stable renal transplant recipients initially treated with a triple drug regimen. J Am Soc Nephrol. 2002;13:536–543.
  • Abramowicz D, del Carmen Rial M, Vitko S, et al.; Cyclosporine Withdrawal Study G. Cyclosporine withdrawal from a mycophenolate mofetil-containing immunosuppressive regimen: results of a five-year, prospective, randomized study. J Am Soc Nephrol. 2005;16:2234–2240.
  • Moore J, Middleton L, Cockwell P, et al. Calcineurin inhibitor sparing with mycophenolate in kidney transplantation: a systematic review and meta-analysis. Transplantation. 2009;87:591–605.
  • Strimpakos AS, Karapanagiotou EM, Saif MW, et al. The role of mTOR in the management of solid tumors: an overview. Cancer Treat Rev. 2009;35:148–159.
  • Opelz G, Unterrainer C, Susal C, et al. Immunosuppression with mammalian target of rapamycin inhibitor and incidence of post-transplant cancer in kidney transplant recipients. Nephrol Dial Transplant. 2016;31:1360–1367.
  • Flechner SM, Glyda M, Cockfield S, et al. The ORION study: comparison of two sirolimus-based regimens versus tacrolimus and mycophenolate mofetil in renal allograft recipients. Am J Transplant. 2011;11:1633–1644.
  • Budde K, Becker T, Arns W, et al. Everolimus-based, calcineurin-inhibitor-free regimen in recipients of de-novo kidney transplants: an open-label, randomised, controlled trial. Lancet. 2011;377:837–847. Epub 2011/02/22.
  • Liefeldt L, Brakemeier S, Glander P, et al. Donor-specific HLA antibodies in a cohort comparing everolimus with cyclosporine after kidney transplantation. Am J Transplant. 2012;12:1192–1198. Epub 2012/02/04.
  • Peddi VR, Wiseman A, Chavin K, et al. Review of combination therapy with mTOR inhibitors and tacrolimus minimization after transplantation. Transplant Rev (Orlando). 2013;27:97–107.
  • Budde K, Becker T, Arns W, et al. Everolimus-based, calcineurin-inhibitor-free regimen in recipients of de-novo kidney transplants: an open-label, randomised, controlled trial. Lancet. 2011;377:837–847.
  • Budde K, Lehner F, Sommerer C, et al. Five-year outcomes in kidney transplant patients converted from cyclosporine to everolimus: the randomized ZEUS study. Am J Transplant. 2015;15:119–128.
  • Croze LE, Tetaz R, Roustit M, et al. Conversion to mammalian target of rapamycin inhibitors increases risk of de novo donor-specific antibodies. Transpl Int. 2014;27:775–783.
  • de Sandes-Freitas TV, Felipe CR, Campos EF, et al. Subclinical lesions and donor-specific antibodies in kidney transplant recipients receiving tacrolimus-based immunosuppressive regimen followed by early conversion to sirolimus. Transplantation. 2015;99:2372–2381.
  • Mjornstedt L, Sorensen SS, von Zur Muhlen B, et al. Improved renal function after early conversion from a calcineurin inhibitor to everolimus: a randomized trial in kidney transplantation. Am J Transplant. 2012;12:2744–2753.
  • Lebranchu Y, Snanoudj R, Toupance O, et al. Five-year results of a randomized trial comparing de novo sirolimus and cyclosporine in renal transplantation: the SPIESSER study. Am J Transplant. 2012;12:1801–1810.
  • Walunas TL, Bakker CY, Bluestone JA. CTLA-4 ligation blocks CD28-dependent T cell activation. J Exp Med. 1996;183:2541–2550.
  • Vincenti F, Larsen C, Durrbach A, et al.; Belatacept Study G. Costimulation blockade with belatacept in renal transplantation. N Engl J Med. 2005;353:770–781.
  • Vincenti F, Charpentier B, Vanrenterghem Y, et al. A phase III study of belatacept-based immunosuppression regimens versus cyclosporine in renal transplant recipients (BENEFIT study). Am J Transplant. 2010;10:535–546. Epub 2010/04/27.
  • Durrbach A, Pestana JM, Pearson T, et al. A phase III study of belatacept versus cyclosporine in kidney transplants from extended criteria donors (BENEFIT-EXT study). Am J Transplant. 2010;10:547–557.
  • Vincenti F, Rostaing L, Grinyo J, et al. Belatacept and long-term outcomes in kidney transplantation. N Engl J Med. 2016;374:333–343.
  • Ferguson R, Grinyo J, Vincenti F, et al. Immunosuppression with belatacept-based, corticosteroid-avoiding regimens in de novo kidney transplant recipients. Am J Transplant. 2011;11:66–76.
  • Kirk AD, Guasch A, Xu H, et al. Renal transplantation using belatacept without maintenance steroids or calcineurin inhibitors. Am J Transplant. 2014;14:1142–1151.
  • D’Addio F, Yuan X, Habicht A, et al. A novel clinically relevant approach to tip the balance toward regulation in stringent transplant model. Transplantation. 2010;90:260–269.
  • Webber AB, Vincenti F. An update on calcineurin inhibitor-free regimens: the need persists, but the landscape has changed. Transplantation. 2016;100:836–843.
  • Rostaing L, Massari P, Garcia VD, et al. Switching from calcineurin inhibitor-based regimens to a belatacept-based regimen in renal transplant recipients: a randomized phase II study. Clin J Am Soc Nephrol. 2011;6:430–439.
  • Grinyo J, Alberu J, Contieri FL, et al. Improvement in renal function in kidney transplant recipients switched from cyclosporine or tacrolimus to belatacept: 2-year results from the long-term extension of a phase II study. Transpl Int. 2012;25:1059–1064.
  • 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. 2017;17:432–442. Epub 2016/06/25.
  • Kuypers DR, 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. Epub 2012/12/25.
  • Rostaing L, Bunnapradist S, Grinyo 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;67:648–659. Epub 2016/01/01.
  • Thomusch O, Wiesener M, Opgenoorth M, et al. Rabbit-ATG or basiliximab induction for rapid steroid withdrawal after renal transplantation (Harmony): an open-label, multicentre, randomised controlled trial. Lancet. 2017;388:3006–3016. Epub 2016/11/23.
  • Budde K, Sommerer C, Becker T, et al. Sotrastaurin, a novel small molecule inhibiting protein kinase C: first clinical results in renal-transplant recipients. Am J Transplant. 2010;10:571–581. Epub 2010/02/04.
  • van Gurp E, Weimar W, Gaston R, et al. Phase 1 dose-escalation study of CP-690 550 in stable renal allograft recipients: preliminary findings of safety, tolerability, effects on lymphocyte subsets and pharmacokinetics. Am J Transplant. 2008;8:1711–1718.
  • Vincenti F, Tedesco SH, Busque S, et al. Randomized phase 2b trial of tofacitinib (CP-690,550) in de novo kidney transplant patients: efficacy, renal function and safety at 1 year. Am J Transplant. 2012;12:2446–2456. Epub 2012/06/12.
  • Vincenti F, Silva HT, Busque S, et al. Evaluation of the effect of tofacitinib exposure on outcomes in kidney transplant patients. Am J Transplant. 2015;15:1644–1653.
  • Vo AA, Zeevi A, Choi J, et al. A phase I/II placebo-controlled trial of C1-inhibitor for prevention of antibody-mediated rejection in HLA sensitized patients. Transplantation. 2015;99:299–308.
  • Sidiropoulos PI, Boumpas DT. Lessons learned from anti-CD40L treatment in systemic lupus erythematosus patients. Lupus. 2004;13:391–397.
  • Goldwater R, Keirns J, Blahunka P, et al. A phase 1, randomized ascending single-dose study of antagonist anti-human CD40 ASKP1240 in healthy subjects. Am J Transplant. 2013;13:1040–1046.
  • Cordoba F, Wieczorek G, Audet M, et al. A novel, blocking, Fc-silent anti-CD40 monoclonal antibody prolongs nonhuman primate renal allograft survival in the absence of B cell depletion. Am J Transplant. 2015;15:2825–2836. Epub 2015/07/04.
  • Larsen CP, Elwood ET, Alexander DZ, et al. Long-term acceptance of skin and cardiac allografts after blocking CD40 and CD28 pathways. Nature. 1996;381:434–438.
  • Malvezzi P, Jouve T, Rostaing L. Costimulation blockade in kidney transplantation: an update. Transplantation. 2016;100:2315–2323.
  • Nankivell BJ, Alexander SI. Rejection of the kidney allograft. N Engl J Med. 2010;363:1451–1462. Epub 2010/10/12.
  • Susal C, Dohler B, Ruhenstroth A, et al.; Collaborative Transplant Study R. Donor-specific antibodies require preactivated immune system to harm renal transplant. EBioMedicine. 2016;9:366–371.
  • Susal C, Ovens J, Mahmoud K, et al. No association of kidney graft loss with human leukocyte antigen antibodies detected exclusively by sensitive Luminex single-antigen testing: a collaborative transplant study report. Transplantation. 2011;91:883–887.
  • Morath C, Opelz G, Zeier M, et al. Prevention of antibody-mediated kidney transplant rejection. Transpl Int. 2012;25:633–645.
  • Everly MJ, Rebellato LM, Haisch CE, et al. Incidence and impact of de novo donor-specific alloantibody in primary renal allografts. Transplantation. 2013;95:410–417.
  • Becker LE, Morath C, Suesal C. Immune mechanisms of acute and chronic rejection. Clin Biochem. 2016;49:320–323.
  • Chung BH, Yang CW. Current issues in the treatment of chronic antibody-mediated rejection in kidney transplantation. Hanyang Med Rev. 2014;34:211–216.
  • Cornell LD, Schinstock CA, Gandhi MJ, et al. Positive crossmatch kidney transplant recipients treated with eculizumab: outcomes beyond 1 year. Am J Transplant. 2015;15:1293–1302.
  • Montgomery RA, Orandi BJ, Racusen L, et al. Plasma-derived C1 esterase inhibitor for acute antibody-mediated rejection following kidney transplantation: results of a randomized double-blind placebo-controlled pilot study. Am J Transplant. 2016;16:3468–3478.
  • Morath C, Opelz G, Zeier M, et al. Clinical relevance of HLA antibody monitoring after kidney transplantation. J Immunol Res. 2014;2014:845040.
  • Sellares 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;12:388–399. Epub 2011/11/16.
  • Opelz G, Dohler B. Effect on kidney graft survival of reducing or discontinuing maintenance immunosuppression after the first year posttransplant. Transplantation. 2008;86:371–376. Epub 2008/08/14.
  • Morath C, Schmitt A, Kalble F, et al. Cell therapeutic approaches to immunosuppression after clinical kidney transplantation. Pediatr Nephrol. 2017. Epub 2017/02/24.
  • Morath C, Zeier M. Transplantation: molecular diagnosis of kidney transplant rejection. Nat Rev Nephrol. 2014;10:429–430.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.