55
Views
0
CrossRef citations to date
0
Altmetric
Review

Next-generation calcineurin inhibitors in development for the prevention of organ rejection

, &
Pages 23-30 | Published online: 25 Mar 2014

References

  • Ekberg H, Grinyó J, Nashan B, et al. Cyclosporine sparing with mycophenolate mofetil, daclizumab and corticosteroids in renal allograft recipients: the CAESAR Study. Am J Transplant. 2007;7(3):560–570.
  • Johnson RW, Kreis H, Oberbauer R, Brattström C, Claesson K, Eris J. Sirolimus allows early cyclosporine withdrawal in renal transplantation resulting in improved renal function and lower blood pressure. Transplantation. 2001;72(5):777–786.
  • Larson TS, Dean PG, Stegall MD, et al. Complete avoidance of calcineurin inhibitors in renal transplantation: a randomized trial comparing sirolimus and tacrolimus. Am J Transplant. 2006;6(3):514–522.
  • Busque S, Leventhal J, Brennan DC, et al. Calcineurin-inhibitor-free immunosuppression based on the JAK inhibitor CP-690,550: a pilot study in de novo kidney allograft recipients. Am J Transplant. 2009;9(8):1936–1945.
  • 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(3):535–546.
  • 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(3):547–557.
  • 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(8):1876–1885.
  • Weir MR, Mulgaonkar S, Chan L, et al. Mycophenolate mofetil-based immunosuppression with sirolimus in renal transplantation: a randomized, controlled Spare-the-Nephron trial. Kidney Int. 2011;79(8): 897–907.
  • Flechner SM. Can the nephron be spared? Kidney Int. 2011;79(8): 804–806.
  • Shamseddin MK, Gupta A. Sirolimus: not so sparing in the Spare-the-Nephron trial. Kidney Int. 2011;79(12):1379; author reply 1379–1380.
  • Teperman L, Moonka D, Sebastian A, et al. Spare-the-Nephron Trial Liver Transplantation Study Group. Calcineurin inhibitor-free mycophenolate mofetil/sirolimus maintenance in liver transplantation: the randomized spare-the-nephron trial. Liver Transpl. 2013;19(7):675–689.
  • Graeb C, Arbogast H, Guba M, Jauch KW, Land W. Cyclosporine: 20 years of experience at the University of Munich. Transplant Proc. 2004;36(2):125S–129S.
  • Sobell JM, Hallas SJ. Systemic therapies for psoriasis: understanding current and newly emerging therapies. Semin Cutan Med Surg. 2003;22(3):187–195.
  • Hamawy MM. Molecular actions of calcineurin inhibitors. Drug News Perspect. 2003;16(5):277–282.
  • Dumont FJ. Cyclosporine A and tacrolimus (FK-506) immunosuppression through immunophilin-dependent inhibition of calcineurin function. In: Lieberman R, Mukherjee A, editors. Principles of Drug Development in Transplantation and Autoimmunity. New York: Chapman and Hall; 1996;1:175–205.
  • Ho S, Clipstone N, Timmermann L, et al. The mechanism of action of cyclosporin A and FK506. Clin Immunol Immunopathol. 1996; 80(3 Pt 2):S40–S45.
  • Cho ML, Cho CS, Min SY, et al. Cyclosporine inhibition of vascular endothelial growth factor production in rheumatoid synovial fibroblasts. Arthritis Rheum. 2002;46(5):1202–1209.
  • Burdmann EA, Andoh TF, Yu L, Bennett WM. Cyclosporine nephrotoxicity. Semin Nephrol. 2003;23(5):465–476.
  • Serkova NJ, Christians U, Benet LZ. Biochemical mechanisms of cyclosporine neurotoxicity. Mol Interv. 2004;4(2):97–107.
  • Shah MB, Martin JE, Schroeder TJ, First MR. The evaluation of the safety and tolerability of two formulations of cyclosporine: neoral and sandimmune. A meta-analysis. Transplantation. 1999;67(11):1411–1417.
  • Aspeslet L, Freitag D, Trepanier D, et al. ISA(TX)247 a novel calcineurin inhibitor. Transplant Proc. 2001;33(1–2):1048–1051.
  • Ling SY, Huizinga RB, Mayo PR, Freitag DG, Aspeslet LJ, Foster RT. Pharmacokinetics of voclosporin in renal impairment and hepatic impairment. J Clin Pharmacol. 2013;53(12):1303–1312.
  • Schreiber SL, Crabtree GR. The mechanism of action of cyclosporin A and FK506. Immunol Today. 1992;13(4):136–142.
  • Stalder M, Bîrsan T, Hubble RW, Paniagua RT, Morris RE. In vivo evaluation of the novel calcineurin inhibitor ISATX247 in non-human primates. J Heart Lung Transplant. 2003;22(12):1343–1352.
  • Dumont FJ. ISAtx-247 (Isotechnika/Roche). Curr Opin Investig Drugs. 2004;5(5):542–550.
  • Yatscoff R, Abel M, Aspeslet L, et al. Phase 2 randomized, multicenter, open-label study of ISA247 and Neoral in post-renal transplant patients. Am J Transplant. 2003;5:463. Abstract.
  • Wasel N, Gupta A, Tomi Z, et al. Pharmacokinetics and pharmacodynamics of ISA247 in a Phase III randomized, multicenter, double-blind, placebo-controlled study. J Am Acad Dermatol. 2006;54(Suppl 1):P36. Abstract.
  • Aspeslet L, Freitag D, Huizinga RB, et al. Pharmacokinetics-pharmacodynamics and safety of Trans-ISA247: A novel immunosuppressant. Poster presented at: Proceedings of the 3rd International Congress on Immunosuppression; December 8–11, 2004; San Diego, CA: 150367.
  • Abel MD, Aspeslet LJ, Freitag DG, et al. ISATX247: a novel calcineurin inhibitor. J Heart Lung Transplant. 2001;20(2):161.
  • Bîrsan T, Dambrin C, Freitag DG, Yatscoff RW, Morris RE. The novel calcineurin inhibitor ISA247: a more potent immunosuppressant than cyclosporine in vitro. Transpl Int. 2005;17(12):767–771.
  • Cunningham MA, Li Z, Chan CC, et al. Subcutaneous injections of LX211 prevent and reverse experimental autoimmune uveoretinitis in rats. Proceedings of the Association for Research in Vision and Ophthalmology Annual Meeting; May 6–10, 2007; Fort Lauderdale, FL: B730.
  • Stalder M, Bîrsan T, Hubble RW, Paniagua RT, Morris RE. In vivo evaluation of the novel calcineurin inhibitor ISATX247 in non-human primates. J Heart Lung Transplant. 2003;22(12):1343–1352.
  • Anglade E, Aspeslet LJ, Weiss SL. A new agent for the treatment of noninfectious uveitis: rationale and design of three LUMINATE (Lux Uveitis Multicenter Investigation of a New Approach to Treatment) trials of steroid-sparing voclosporin. Clin Ophthalmol. 2008;2(4):693–702.
  • Freitag D, Mayo P, Aspeslet L, et al. The novel immunosuppressant ISA247 demonstrates a different metabolic profile than cyclosporine A in vitro and in vivo. Proceedings of the World Transplant Congress; July 22–27, 2006; Boston, MA: 2434.
  • Bissonnette R, Papp K, Poulin Y, et al; ISA247 Psoriasis Study Group. A randomized, multicenter, double-blind, placebo-controlled phase 2 trial of ISA247 in patients with chronic plaque psoriasis. J Am Acad Dermatol. 2006;54(3):472–478.
  • Papp K, Bissonnette R, Rosoph L, et al. Efficacy of ISA247 in plaque psoriasis: a randomised, multicentre, double-blind, placebo-controlled phase III study. Lancet. 2008;371(9621):1337–1342.
  • Gaston R, Busque S, Cantarovich M, et al. for the PROMISE Study Investigators. ISA247: A novel calcineurin inhibitor (CNI). A promising safety profile with enhanced efficacy [poster]. Proceedings of the American Society of Nephrology,; San Diego, CA, USA. 2006. Clin Ophthalmol. 2008 December; 2(4): 693–702. Published online 2008 December. PMCID: PMC2699819 A new agent for the treatment of noninfectious uveitis: rationale and design of three LUMINATE (Lux Uveitis Multicenter Investigation of a New Approach to Treatment) trials of steroid-sparing voclosporin.
  • Busque S, Laftavi M, Gaston R, et al. ISA247: Preliminary results of a phase IIb multicentre, de novo renal transplant trial. Abstract presented at: Proceedings of the American Transplant Congress; May 6, 2007; San Francisco, CA: 49. Clin Ophthalmol. 2008 December; 2(4): 693–702. Published online 2008 December. PMCID: PMC2699819 A new agent for the treatment of noninfectious uveitis: rationale and design of three LUMINATE (Lux Uveitis Multicenter Investigation of a New Approach to Treatment) trials of steroid-sparing voclosporin.
  • Busque S, Cantarovich M, Mulgaonkar S, et al; PROMISE Investigators. The PROMISE study: a phase 2b multicenter study of voclosporin (ISA247) versus tacrolimus in de novo kidney transplantation. Am J Transplant. 2011;11(12):2675–2684.
  • Vincenti F, Larsen C, Durrbach A, et al; Belatacept Study Group. Costimulation blockade with belatacept in renal transplantation. N Engl J Med. 2005;353(8):770–781.
  • Vincenti F, Friman S, Scheuermann E, et al; DIRECT (Diabetes Incidence after Renal Transplantation: Neoral C Monitoring Versus Tacrolimus) Investigators. Results of an international, randomized trial comparing glucose metabolism disorders and outcome with cyclosporine versus tacrolimus. Am J Transplant. 2007;7(6):1506–1514.
  • Øzbay LA, Smidt K, Mortensen DM, Carstens J, Jørgensen KA, Rungby J. Cyclosporin and tacrolimus impair insulin secretion and transcriptional regulation in INS-1E beta-cells. Br J Pharmacol. 2011;162(1):136–146.
  • Heit JJ, Apelqvist AA, Gu X, et al. Calcineurin/NFAT signalling regulates pancreatic beta-cell growth and function. Nature. 2006;443(7109): 345–349.
  • Gupta A, Tomi Z, Kunynetz R, et al. Pharmacokinetics and pharmacodynamics of ISA247 in a Phase III, randomized, multicentre, double-blind, placebo-controlled study. Abstract presented at: The Canadian Dermatology Association 81st Annual Conference; June 27–July 2, 2006; Winnipeg, Manitoba.
  • Grinyó JM, Ekberg H, Mamelok RD, et al. The pharmacokinetics of mycophenolate mofetil in renal transplant recipients receiving standard-dose or low-dose cyclosporine, low-dose tacrolimus or low-dose sirolimus: the Symphony pharmacokinetic substudy. Nephrol Dial Transplant. 2009;24(7):2269–2276.
  • Isotechnika, Inc. [Accessed July 8, 2007]; Phase 3 Canadian Psoriasis Study. 2007b URL: http://www.isotechnika.com/in_development/isa247/psoriasis.
  • Langley R, Bissonnette R, Searles G, et al. 24 Week results of a Phase III randomized, double-blind, multicentre, placebo-controlled study of ISA247 in plaque psoriasis. Abstract presented at: The Canadian Dermatology Association 81st Annual Conference; June 27–July 2, 2006; Winnipeg, Manitoba.
  • Papp K, Langley R, Bissonnette R, et al. A Phase III, randomized, multicenter, double-blind, placebo-controlled study of ISA247 in plaque psoriasis patients. J Am Acad Dermatol. 2004;54(Suppl 1):P33. Abstract.
  • Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation. Clin Pharmacokinet. 2004;43(10):623–653.
  • Vollenbroeker B, Koch JH, Fobker M, Suwelack B, Hohage H, Müller U. Determination of cyclosporine and its metabolites in blood via HPLC-MS and correlation to clinically important parameters. Transplant Proc. 2005;37(4):1741–1744.
  • Yatscoff RW, Broski AP, Abel MD, et al. Phase 2 trial results of ISATX247, a novel calcineurin inhibitor with a therapeutic window. Abstract presented at: Proceedings of the IXI International Congress of The Transplantation Society; April 29, 2002; Miami, FL: 0471.
  • Hougardy JM, Broeders N, Kianda M, et al. Conversion from Prograf to Advagraf among kidney transplant recipients results in sustained decrease in tacrolimus exposure. Transplantation. 2011;91(5): 566–569.
  • Tanaka T, Takatsuki M, Soyama A, et al. Evaluation of immune function under conversion from Prograf to Advagraf in living donor liver transplantation. Ann Transplant. 2013;18:293–298.
  • Carcas-Sansuán AJ, Espinosa-RomÁn L, Almeida-Paulo GN, et al. Conversion from Prograf to Advagraf in stable paediatric renal transplant patients and 1-year follow-up. Pediatr Nephrol. 2014;29(1):117–123.
  • Wu SW, Tsai HC, Tsai PY, Hung TW, Chang HR, Lian JD. Conversion to prolonged release tacrolimus formulation in stable kidney transplant recipients. Swiss Med Wkly. 2013;143:w13850.
  • Albano L, Banas B, Klempnauer JL, Glyda M, Viklicky O, Kamar N; Optimising immunoSuppression After Kidney transplantation with ADVAGRAF (OSAKA) study group. OSAKA Trial: A Randomized, Controlled Trial Comparing Tacrolimus QD and BD in Kidney Transplantation. Transplantation. 2013;96(10):897–903.
  • Carcas-Sansuán AJ, Hierro L, Almeida-Paulo GN, et al. Conversion from Prograf to Advagraf in adolescents with stable liver transplants: comparative pharmacokinetics and 1-year follow-up. Liver Transpl. 2013;19(10):1151–1158.
  • Ma MK, Kwan LP, Mok MM, Yap DY, Tang CS, Chan TM. Significant reduction of Tacrolimus trough level after conversion from twice daily Prograf to once daily Advagraf in Chinese renal transplant recipients with or without concomitant diltiazem treatment. Ren Fail. 2013;35(7):942–945.
  • Ghodsizad A, Koch A, Ungerer MN, et al. Immunosuppression with tacrolimus early after orthotopic heart transplantation: a comparison of prograf and advagraf. Heart Surg Forum. 2012;15(6): E307–E309.
  • Kuypers DR, Peeters PC, Sennesael JJ, et al; ADMIRAD Study Team. Improved adherence to tacrolimus once-daily formulation in renal recipients: a randomized controlled trial using electronic monitoring. Transplantation. 2013;95(2):333–340.