Induction therapy and mTOR inhibition: Minimizing calcineurin inhibitor exposure in de novo renal transplant patients

Clinical Transplantation

Volumn 27, Issue S25, 2013, Pages 16-29

  Nashan, Björn ^a  

^a UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

Author keywords

Antithymocyte globulin; Basiliximab; Calcineurin inhibitors; Daclizumab; Everolimus; Induction; Kidney transplantation; Minimization; MTOR inhibitors; Sirolimus

Indexed keywords

BASILIXIMAB; CALCINEURIN INHIBITOR; EVEROLIMUS; INTERLEUKIN 2 RECEPTOR; MAMMALIAN TARGET OF RAPAMYCIN; MAMMALIAN TARGET OF RAPAMYCIN INHIBITOR; MYCOPHENOLIC ACID; RAPAMYCIN; STEROID; TACROLIMUS; THYMOCYTE ANTIBODY;

ARTICLE; CELL PROLIFERATION; CYTOMEGALOVIRUS INFECTION; DRUG EFFICACY; DRUG EXPOSURE; DRUG SAFETY; FOLLOW UP; GRAFT FAILURE; GRAFT RECIPIENT; HUMAN; IMMUNE RESPONSE; INCIDENCE; KIDNEY FUNCTION; KIDNEY GRAFT; KIDNEY TRANSPLANTATION; LIVING DONOR; LONG TERM MEMORY; MEMORY CELL; PRIORITY JOURNAL; WOUND HEALING;

ANTITHYMOCYTE GLOBULIN; BASILIXIMAB; CALCINEURIN INHIBITORS; DACLIZUMAB; EVEROLIMUS; INDUCTION; KIDNEY TRANSPLANTATION; MINIMIZATION; MTOR INHIBITORS; SIROLIMUS;

CALCINEURIN; GRAFT REJECTION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; INTERLEUKIN-2 RECEPTOR ALPHA SUBUNIT; KIDNEY DISEASES; KIDNEY TRANSPLANTATION; POSTOPERATIVE COMPLICATIONS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REMISSION INDUCTION; TOR SERINE-THREONINE KINASES;

EID: 84881260715     PISSN: 09020063     EISSN: 13990012     Source Type: Journal    
DOI: 10.1111/ctr.12156     Document Type: Article

References (72)

1. Boots JM, Christiaans MH, van Hooff JP. Effect of immunosuppressive agents on long-term survival of renal transplant recipients: focus on the cardiovascular risk. Drugs 2004: 64: 2047.
2. Marcén R. Immunosuppressive drugs in kidney transplantation: impact on patient survival, and incidence of cardiovascular disease, malignancy and infection. Drugs 2009: 69: 2227.
3. Gutierrez-Dalmau A, Campistol JM. Immunosuppressive therapy and malignancy in organ transplant recipients: a systematic review. Drugs 2007: 67: 1167.
4. Nankivell BJ, Borrow RJ, Fung CL-S, O'Connell PJ, Chapman JR, Allen RD. Calcineurin inhibitor nephrotoxicity: longitudinal assessment by protocol histology. Transplantation 2004: 78: 557.
5. Sharif A, Shabir S, Chand S, Cockwell P, Ball S, Borrows R. Meta-analysis of calcineurin-inhibitor-sparing regimens in kidney transplantation. J Am Soc Nephrol 2011: 22: 2107.
6. 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.
7. Zeier M, Van Der Giet M. Calcineurin inhibitor sparing regimens using m-target of rapamycin inhibitors: an opportunity to improve cardiovascular risk following kidney transplantation? Transpl Int 2011: 24: 30.
8. Placebo-controlled study of mycophenolate mofetil combined with cyclosporine and corticosteroids for prevention of acute rejection. European Mycophenolate Mofetil Cooperative Study Group. Lancet 1995: 345: 1321.
9. Sollinger HW. Mycophenolate mofetil for the prevention of acute rejection in primary cadaveric renal allograft recipients. U.S. Renal Transplant Mycophenolate Mofetil Study Group. Transplantation 1995: 60: 225.
10. A blinded, randomized clinical trial of mycophenolate mofetil for the prevention of acute rejection in cadaveric renal transplantation. The Tricontinental Mycophenolate Mofetil Renal Transplantation Study Group. Transplantation 1996: 61: 1029.
11. Vincenti F, Ramos E, Brattstrom C et al. Multicenter trial exploring calcineurin inhibitors avoidance in renal transplantation. Transplantation 2001: 71: 1282.
12. Huang E, Cho YW, Hayashi R, Bunnapradist S. Alemtuzumab induction in deceased donor kidney transplantation. Transplantation 2007: 84: 821.
13. Lebranchu Y, Bridoux E, Büchler M et al. Immunoprophylaxis with basiliximab compared with antithymocyte globulin in renal transplant patients receiving MMF-containing triple therapy. Am J Transplant 2002: 2: 48.
14. Kamar N, Garrique V, Karras A et al. Impact of early or delayed cyclosporine on delayed graft function in renal transplant recipients: a randomized, multicenter study. Am J Transplant 2006: 6: 1042.
15. 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: 560.
16. Ekberg H, Tedesco-Silva H, Demirbas A et al. Reduced exposure to calcineurin inhibitors in renal transplantation. N Engl J Med 2007: 357: 2562.
17. Schuler W, Sedrani R, Cottens S et al. SDZ RAD, a new rapamycin derivative: pharmacological properties in vitro and in vivo. Transplantation 1997: 64: 36.
18. ®): 25 years and new frontiers in solid organ transplantation and haematology. Drugs 2010: 70: 691.
19. Knechtle SJ, Pirsch JD, Fechner JH Jr et al. Campath-1H induction plus rapamycin monotherapy for renal transplantation: results of a pilot study. Am J Transplant 2003: 3: 722.
20. Morris JC, Waldmann TA. Advances in interleukin 2 receptor targeted treatment. Ann Rheum Dis 2000: 59(Suppl. 1): i109.
21. Finlay D, Cantrell D. Phosphoinositide 3-kinase and the mammalian target of rapamycin pathways control T cell migration. Ann N Y Acad Sci 2010: 1183: 149.
22. Song J, Lei FT, Xiong X, Haque R. Intracellular signals of T cell costimulation. Cell Mol Immunol 2008: 5: 239.
23. Colombetti S, Basso V, Mueller DL, Mondino A. Prolonged TCR/CD28 engagement drives IL-2-independent T cell clonal expansion through signaling mediated by the mammalian target of rapamycin. J Immunol 2006: 176: 2730.
24. Abraham RT. Mammalian target of rapamycin: immunosuppressive drugs uncover a novel pathway of cytokine receptor signaling. Curr Opin Immunol 1998: 10: 330.
25. Noël C, Abramowicz D, Durand D et al. Daclizumab versus antithymocyte globulin in high-immunological-risk renal transplant recipients. J Am Soc Nephrol 2009: 20: 1385.
26. Brennan DC, Daller JA, Lake KD, Cibrik D, Del Castillo D. Thymoglobin Induction Study Group. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med 2006: 355: 1967.
27. Ciancio G, Burke GW, Gaynor JJ et al. A randomized trial of three renal transplant induction antibodies: early comparison of tacrolimus, mycophenolate mofetil, and steroid dosing, and newer immune-monitoring. Transplantation 2005: 80: 457.
28. Abou-Ayache R, Büchler M, Lepogamp P et al. CMV infections after two doses of daclizumab versus thymoglobulin in renal transplant patients receiving mycophenolate mofetil, steroids and delayed cyclosporine A. Nephrol Dial Transplant 2008: 23: 2024.
29. Mourad G, Rostaing L, Legendre C, Garrigue V, Thervet E, Durand D. Sequential protocols using basiliximab versus antithymocyte globulins in renal-transplant patients receiving mycophenolate mofetil and steroids. Transplantation 2004: 78: 584.
30. Kyllönen LE, Eklund BH, Pesonen EJ, Salmela KT. Single bolus antithymocyte globulin versus basiliximab induction in kidney transplantation with cyclosporine triple immunosuppression: efficacy and safety. Transplantation 2007: 84: 75.
31. Kim MJ, Tsinalis D, Franz S et al. ATG-Fresenius or daclizumab induction therapy in immunologically high risk kidney recipients: a prospective randomized pilot trial. Ann Transplant 2008: 13: 21.
32. Sollinger H, Kaplan B, Pescovitz MD et al. Basiliximab versus antithymocyte globulin for prevention of acute renal allograft rejection. Transplantation 2001: 72: 1915.
33. Lawen JG, Davies EA, Mourad G et al. Randomized double-blind study of immunoprophylaxis with basiliximab, a chimeric anti-interleukin-2 receptor monoclonal antibody, in combination with mycophenolate mofetil-containing triple therapy in renal transplantation. Transplantation 2003: 75: 37.
34. Nashan B, Moore R, Amlot P, Schmidt AG, Abeywickrama K, Soulillou JP. Randomised trial of basiliximab versus placebo for control of acute cellular rejection in renal allograft recipients. CHIB 201 International Study Group. Lancet 1997: 350: 1193.
35. Vincenti F, Kirkman R, Light S et al. Interleukin-1-receptor blockade with daclizumab to prevent acute rejection in renal transplantation. N Engl J Med 1998: 38: 161.
36. Nashan B, Light S, Hardie IR, Lin A, Johnson JR. Reduction of acute renal allograft rejection by daclizumab. Daclizumab Double Therapy Study Group. Transplantation 1999: 67: 110.
37. Waller EK, Langston AA, Lonial S et al. Pharma-cokinetics and pharmacodynamics of anti-thymocyte globulin in recipients of partially HLA-matched blood hematopoietic progenitor cell transplantation. Biol Blood Marrow Transplant 2003: 9: 460.
38. Caillard S, Dharnidharka V, Agodoa L, Bohen E, Abbott K. Posttransplant lymphoproliferative disorders after renal transplantation in the United States in era of modern immunosuppression. Transplantation 2005: 80: 1233.
39. Bustami RT, Ojo AO, Wolfe RA et al. Immunosuppression and the risk of post-transplant malignancy among cadaveric first kidney transplant recipients. Am J Transplant 2004: 4: 87.
40. Cherikh WS, Kauffman HM, McBride MA, Maghirang J, Swinnen LJ, Hanto DW. Association of the type of induction immunosuppression with posttransplant lymphoproliferative disorder, graft survival, and patient survival after primary kidney transplantation. Transplantation 2003: 76: 1289.
41. Glotz D, Charpentier B, Abramovicz D et al. Thymoglobulin induction and sirolimus versus tacrolimus in kidney transplant recipients receiving mycophenolate mofetil and steroids. Transplantation 2010: 89: 1511.
42. Flechner SM, Goldfarb D, Modlin C et al. Kidney transplantation without calcineurin inhibitor drugs: a prospective, randomized trial of sirolimus versus cyclosporine. Transplantation 2002: 74: 1070.
43. Kreis H, Cisterne JM, Land W et al. Sirolimus in association with mycophenolate mofetil induction for the prevention of acute graft rejection in renal allograft recipients. Transplantation 2000: 69: 1252.
44. 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: 514.
45. Stegall MD, Larson TS, Prieto M et al. Kidney transplantation without calcineurin inhibitors using sirolimus. Transplant Proc 2003: 35(Suppl. 3): 125S.
46. Lo A, Egidi MF, Gaber LW et al. Observations regarding the use of sirolimus and tacrolimus in high-risk cadaveric renal transplantation. Clin Transplant 2004: 18: 53.
47. Tedesco Silva H Jr, Cibrik D, Johnston T et al. Everolimus plus reduced-exposure CsA versus mycophenolic acid plus standard-exposure CsA in renal-transplant recipients. Am J Transplant 2010: 10: 1401.
48. Salvadori M, Scolari MP, Bertoni E et al. Everolimus with very low-exposure cyclosporine A in de novo kidney transplantation: a multicenter, randomized, controlled trial. Transplantation 2009: 88: 1194.
49. Kandaswamy R, Melancon JK, Dunn T et al. A prospective randomized trial of steroid-free maintenance regimens in kidney transplant recipients-an interim analysis. Am J Transplant 2005: 5: 1529.
50. Ferreira AN, Machado PG, Felipe CR et al. Concentration-controlled use of sirolimus associated with reduced exposure of cyclosporine in black recipients of primarily living renal allograft donors: 12-month results. Clin Transplant 2005: 19: 607.
51. Vitko S, Tedesco H, Eris J et al. Everolimus with optimized cyclosporine dosing in renal transplant recipients: 6-month safety and efficacy results of two randomized trials. Am J Transplant 2004: 4: 626.
52. Bertoni E, Larti A, Rosso G, Zanazzi M, Di Maria L, Salvadori M. Good outcomes with cyclosporine very low exposure with everolimus high exposure in renal transplant patients. J Nephrol 2011: 24: 613.
53. Albano L, Berthoux F, Moal M-C et al. RAD A2420 Study Group. Incidence of delayed graft function and wound healing complications after deceased-donor kidney transplantation is not affect by de novo everolimus. Transplantation 2009: 88: 69.
54. Ciancio G, Burke GW, Gaynor JJ et al. A randomized long-term trial of tacrolimus and sirolimus versus tacrolimus and mycophenolate mofetil versus cyclosporine (NEORAL) and sirolimus in renal transplantation. I. Drug interactions and rejection at one year. Transplantation 2004: 77: 244.
55. Ciancio G, Burke GW, Gaynor JJ et al. A randomized long-term trial of tacrolimus/sirolimus versus tacrolimus/mycophenolate mofetil versus cyclosporine (NEORAL)/sirolimus in renal transplantation. II. Survival, function, and protocol compliance at 1 year. Transplantation 2004: 77: 25.
56. Nashan B, Curtis J, Ponticelli C et al. Everolimus and reduced-exposure cyclosporine in de novo renal-transplant recipients: a three-year phase II, randomized, multicenter, open-label study. Transplantation 2004: 78: 1332.
57. Chan L, Greenstein S, Hardy MA et al. Multicenter, randomized study of the use of everolimus with tacrolimus after renal transplantation demonstrates its effectiveness. Transplantation 2008: 85: 821.
58. Eisen HJ, Pauly D, Starling R et al. Efficacy and renal function in de novo heart transplant recipients receiving everolimus with reduced CsA compared to MMF with standard CsA: the A2310 study. Am J Transplant 2011: 11(Suppl. 2): Abstract 330.
59. ® Summary of Product Characteristics. Novartis Sverige AB, Täby, Sweden. Updated October 2011.
60. Vitko S, Margreiter R, Weimar W et al. Three-year efficacy and safety results from a study of everolimus versus mycophenolate mofetil in de novo renal transplant patients. Am J Transplant 2005: 5: 2521.
61. Van Gurp E, Bustamente J, Franco A et al. Comparable renal function at 6 months with tacrolimus combined with fixed-dose sirolimus or MMF: results of a randomized multicenter trial in renal transplantation. J Transplant 2010: 2010: 731426.
62. Guerra G, Ciancio G, Gaynor JJ et al. Randomized trial of immunosuppressive regimens in renal transplantation. J Am Soc Nephrol 2011: 22: 1758.
63. Montagnino G, Sandrini S, Iorio B et al. A randomized exploratory trial of steroid avoidance in renal transplant patients treated with everolimus and low-dose cyclosporine. Nephrol Dial Transplant 2008: 23: 707.
64. Nashan B, Citterio F. Wound healing complications and the use of mammalian target of rapamycin inhibitors in kidney transplantation: a critical review of the literature. Transplantation 2012: 94: 547.
65. Vathsala A, Zibari G, Kim KS et al. Dose related incidences of wound healing events in renal transplant recipients treated with everolimus and cyclosporine. Transplantation 2010: 90: 615 [Abstract].
66. Vincenti F, Schena FP, Paraskevas S et al. Randomized, multicenter study of steroid avoidance, early steroid withdrawal or standard steroid therapy in kidney transplant recipients. Am J Transplant 2008: 8: 307.
67. Eisen HJ, Tuzcu EM, Dorent R et al. Everolimus for the prevention of allograft rejection and vasculopathy in cardiac-transplant recipients. N Engl J Med 2003: 349: 847.
68. Kobashigawa J, Ross H, Kfoury AG et al. CMV infections are less frequent in de novo heart transplant recipients receiving immunosuppression with everolimus plus reduced CsA compared to MMF and standard CsA. Am J Transplant 2011: 11(Suppl. 2): Abstract 335.
69. Araki K, Turner AP, Shaffer VO et al. mTOR regulates memory CD8 T-cell differentiation. Nature 2009: 460: 108.
70. Araki K, Youngblood B, Ahmed R. The role of mTOR in memory CD8 T-cell differentiation. Immunol Rev 2010: 235: 234.
71. Clippinger AJ, Maguire TG, Alwine JC. The changing role of mTOR kinase in the maintenance of protein synthesis during human cytomegalovirus infection. J Virol 2011: 85: 3930.
72. Nashan B, Gaston R, Emery V et al. Review of Cytomegalovirus infection findings with mammalian target of rapamycin inhibitor-based immunosuppressive therapy in de novo renal transplant recipients. Transplantation 2012: 93: 1075.