New treatment approaches in chronic kidney disease-associated anaemia

Expert Opinion on Biological Therapy

Volumn 14, Issue 5, 2014, Pages 687-696

  Del Vecchio, Lucia ^a   Locatelli, Francesco ^a  

^a A MANZONI HOSPITAL   (Italy)

Author keywords

Anaemia; Chronic kidney disease; CNTO; Erythropoiesis; Erythropoietin; Erythropoietin fusion protein; Peginesatide; Prolyl hydroxylase inhibitor; Roxadustat; Sotatercept

Indexed keywords

ABT 007; ACTIVIN A; AKB 6548; ANTIANEMIC AGENT; CNTO 528; CNTO 530; CONTINUOUS ERYTHROPOIESIS RECEPTOR ACTIVATOR; CYCLOPEPTIDE; EPO MIMETIC PEPTIDE; ERYTHROPOIETIN; ERYTHROPOIETIN RECEPTOR; FG 2216; GSK 1278863; HEMOGLOBIN; HYBRID PROTEIN; HYPOXIA INDUCIBLE FACTOR; HYPOXIA INDUCIBLE FACTOR PROLYL HYDROXYLASE INHIBITOR; IRON; LUSPATERCEPT; MOLIDUSTAT; MONOCLONAL ANTIBODY; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; PEGINESATIDE; PEPTIDE DERIVATIVE; PLACEBO; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT PROTEIN; ROXADUSTAT; SOTATERCEPT; UNCLASSIFIED DRUG;

ANEMIA; ANTINEOPLASTIC ACTIVITY; BONE MASS; CELL PROLIFERATION; CHRONIC KIDNEY DISEASE; CLINICAL TRIAL (TOPIC); DISEASE ASSOCIATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; ECONOMIC RECESSION; ERYTHROPOIESIS; GLOMERULUS FILTRATION RATE; HEMATOPOIETIC STEM CELL; HUMAN; MEDLINE; NONHUMAN; OXYGEN SENSING; PHARMACODYNAMICS; PHASE 2 CLINICAL TRIAL (TOPIC); REVIEW; RISK FACTOR; SEQUENCE HOMOLOGY; SIGNAL TRANSDUCTION; TREATMENT INDICATION; COMPLICATION; HEMATOPOIESIS; IMMUNOLOGY; KIDNEY FAILURE, CHRONIC;

ANEMIA; ANTIBODIES, MONOCLONAL; ERYTHROPOIETIN; HEMATOPOIESIS; HUMANS; KIDNEY FAILURE, CHRONIC; RECEPTORS, ERYTHROPOIETIN;

EID: 84898727895     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/14712598.2014.892577     Document Type: Review

References (65)

1. Mcclellan WM, Aronoff SL, Bolton WK. The prevalence of anaemia in patients with chronic kidney disease. Curr Med Res Opin 2004;20:1501-10
2. Locatelli F, Pisoni RL, Combe C, et al. Anaemia in haemodialysis patients of five European countries: Association with morbidity and mortality in the Dialysis Outcomes and Practice Patterns Study DOPPS). Nephrol Dial Transplant 2004;19:121-32
3. KDIGO clinical practice guideline for anemia in chronic kidney disease. Kidney Int Suppl 2012;2(4):279-335
4. Pisoni RL, Fuller DS, Bieber BA, et al. The DOPPS Practice Monitor for US dialysis care: Trends through August 2011. Am J Kidney Dis 2012;60(1):160-5
5. Available from: Http://omontys.com/ [Last accessed 26 February 2013]
6. Storring PL, Tiplady RJ, Gaines Das RE, et al. Epoetin alfa and beta differ in their erythropoietin isoform compositions and biological properties. Br J Haematol 1998;100:79-89
7. Del Vecchio L, Locatelli F. Safety issues related to erythropoiesis- stimulating agents used to treat anemia in patients with chronic kidney disease. Expert Opin Drug Saf 2012;11(6):923-31
8. Livnah O, Stura EA, Johnson DL, et al. Functional mimicry of a protein hormone by a peptide agonist: The EPO receptor complex at 2.8 A. Science 1996;273(5274):464-71
9. Wrighton NC, Farrell FX, Chang R, et al. Small peptides as potent mimetics of the protein hormone erythropoietin. Science 1996;273(5274):458-64
10. Johnson DL, Farrell FX, Barbone FP, et al. Identification of a 13 amino acid peptide mimetic of erythropoietin and description of amino acids critical for the mimetic activity of EMP1. Biochemistry 1998;37(11):3699-710
11. Fan Q, Leuther KK, Holmes CP, et al. Preclinical evaluation of Hematide, a novel erythropoiesis stimulating agent, for the treatment of anemia. Exp Hematol 2006;34(10):1303-11
12. Bugelski PJ, Capocasale RJ, Makropoulos D, et al. CNTO 530: Molecular pharmacology in human UT-7EPO cells and pharmacokinetics and pharmacodynamics in mice. J Biotechnol 2008;134(1-2):171-80
13. Scully MS, Ort TA, James IE, et al. A novel EPO receptor agonist improves glucose tolerance via glucose uptake in skeletal muscle in a mouse model of diabetes. Exp Diabetes Res 2011;2011:910159
14. Bugelski PJ, Makropoulos D, Spinka-Doms T, et al. Differential effects of long-lived erythropoietin receptor agonists in rats. Anal Acta 2011;2:7
15. Pérez-Ruixo JJ, Krzyzanski W, Bouman-Thio E, et al. Pharmacokinetics and pharmacodynamics of the erythropoietin Mimetibody construct CNTO 528 in healthy subjects. Clin Pharmacokinet 2009;48(9):601-13
16. Bouman-Thio E, Franson K, Miller B, et al. A phase I, single and fractionated, ascending-dose study evaluating the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of an erythropoietin mimetic antibody fusion protein (CNTO 528) in healthy male subjects. J Clin Pharmacol 2008;48(10):1197-207
17. Sytkowski AJ, Lunn ED, Davis KL, et al. Human erythropoietin dimers with markedly enhanced in vivo activity. Proc Natl Acad Sci USA 1998;95:1184-8
18. Dalle B, Henri A, Rouyer-Fessard P, et al. Dimeric erythropoietin fusion protein with enhanced erythropoietic activity in vitro and in vivo. Blood 2001;97(12):3776-82
19. Fares F, Ganem S, Hajouj T, Agai E. Development of a long-Acting erythropoietin by fusing the carboxyl-Terminal peptide of human chorionic gonadotropin beta-subunit to the coding sequence of human erythropoietin. Endocrinology 2007;148(10):5081-7
20. Fares F, Havron A, Fima E. Designing a long acting erythropoietin by fusing three carboxyl-Terminal peptides of human chorionic gonadotropin b subunit to the n-Terminal and c-Terminal coding sequence. Int J Cell Biol 2011;2011:275063
21. Schriebl K, Trummer E, Lattenmayer C, et al. Biochemical characterization of rhEpo-Fc fusion protein expressed in CHO cells. Protein Expr Purif 2006;49(2):265-75
22. Way JC, Lauder S, Brunkhorst B, et al. Improvement of Fc-erythropoietin structure and pharmacokinetics by modification at a disulfide bond. Protein Eng Des Sel 2005;18:111-18
23. Penno CA, Kawabe Y, Ito A, Kamihira M. Production of recombinant human erythropoietin/Fc fusion protein by genetically manipulated chickens. Transgenic Res 2010;19(2):187-95
24. Joung CH, Shin JY, Koo JK, et al. Production and characterization of longacting recombinant human albumin-EPO fusion protein expressed in CHO cell. Protein Expr Purif 2009;68(2):137-45
25. Coscarella A, Liddi R, Di Loreto M, et al. The rhGM-CSF-EPO hybrid protein MEN 11300 induces anti-EPO antibodies and severe anaemia in rhesus monkeys. Cytokine 1998;10:964-9
26. Schneider H, Chaovapong W, Matthews DJ, et al. Homodimerization of erythropoietin receptor by a bivalent monoclonal antibody triggers cell proliferation and differentiation of erythroid precursors. Blood 1997;89:473-82
27. Elliott S, Lorenzini T, Yanagihara D, et al. Activation of the erythropoietin (EPO) receptor by bivalent anti-EPO receptor antibodies. J Biol Chem 1996;271:24691-7
28. Babcook JS, Leslie KB, Olsen OA, et al. A novel strategy for generating monoclonal antibodies from single, isolated lymphocytes producing antibodies of defined specificities. Proc Natl Acad Sci USA 1996;93:7843-8
29. Philo JS, Aoki KH, Arakawa T, et al. Dimerization of the extracellular domain of the erythropoietin (EPO) receptor by EPO: One high-Affinity and one low-Affinity interaction. Biochemistry 1996;35:1681-91
30. Lacy SE, DeVries PJ, Xie N, et al. The potency of erythropoietin-mimic antibodies correlates inversely with affinity. J Immunol 2008;181(2):1282-7
31. Maguer-Satta V, Bartholin L, Jeanpierre S, et al. Regulation of human erythropoiesis by activin A, BMP2, and BMP4, members of the TGFbeta family. Exp Cell Res 2003;282:110-20
32. Lotinun S, Pearsall RS, Davies MV, et al. A soluble activin receptor Type IIA fusion protein (ACE-011) increases bone mass via a dual anabolicantiresorptive effect in Cynomolgus monkeys. Bone 2010;46:1082-8
33. Finberg KE, Whittlesey RL, Fleming MD, Andrews NC. Down-regulation of Bmp/Smad signaling by Tmprss6 is required for maintenance of systemic iron homeostasis. Blood 2010;115(18):3817-26
34. Iancu-Rubin C, Mosoyan G, Wang J, et al. Stromal cell-mediated inhibition of erythropoiesis can be attenuated by Sotatercept (ACE-011), an activin receptor type II ligand trap. Exp Hematol 2013;41(2):155-66
35. Ruckle J, Jacobs M, Kramer W, et al. Single-dose, randomized, double-blind, placebo-controlled study of ACE-011 (ActRIIA-IgG1) in postmenopausal women. J Bone Miner Res 2009;24(4):744-52
36. Raje N, Vallet S. Sotatercept, a soluble activin receptor type 2A IgG-Fc fusion protein for the treatment of anemia and bone loss. Curr Opin Mol Ther 2010;12(5):586-97
37. Zhou L, McMahon C, Bhagat T, et al. Reduced SMAD7 leads to overactivation of TGF-beta signaling in MDS that can be reversed by a specific inhibitor of TGF-beta receptor I kinase. Cancer Res 2011;71(3):955-63
38. Majmundar AJ, Wong WJ, Simon MC. Hypoxia-inducible factors and the response to hypoxic stress. Mol Cell 2010;40(2):294-309
39. Semenza GL. Hypoxia-inducible factors in physiology and medicine. Cell 2012;148(3):399-408
40. Kaelin WG Jr, Ratcliffe PJ. Oxygen sensing by metazoans: The central role of the HIF hydroxylase pathway. Mol Cell 2008;30(4):393-402
41. Percy MJ, Zhao Q, Flores A, et al. A family with erythrocytosis establishes a role for prolyl hydroxylase domain protein 2 in oxygen homeostasis. Proc Natl Acad Sci USA 2006;103:654-9
42. Takeda K, Aguila HL, Parikh NS, et al. Regulation of adult erythropoiesis by prolyl hydroxylase domain proteins. Blood 2008;111(6):3229-35
43. Yoji AM, Kaelin Jr. W.G. Reactivation of hepatic EPO synthesis in mice after PHD loss. Science 2010;329(5990):407
44. Minamishima YA, Moslehi J, Bardeesy N, et al. Somatic inactivation of the PHD2 prolyl hydroxylase causes polycythemia and congestive heart failure. Blood 2008;111(6):3236-44
45. Provenzano R, et al. Pharmacokinetics of oral FG-4592 to treat anemia in hemodialysis patients [abstract 189]. National Kidney Foundation Conference; 2011
46. Besarab A, Hulter HN, Klaus S, et al. FG-4592, a novel oral HIF prolyl hydroxylase inhibitor, elevates hemoglobin in anemic stage 3/4 CKD patients [abstract SA-FC416]. American Society of nephrology Renal Week; 16-21 November 2010; Denver (CO), USA
47. Provenzano R, et al. Evaluation of FG-4592, a novel oral hypoxia-inducible factor prolyl hydroxylase inhibitor, to treat anemia in hemodialysis patients [abstract 188]. National Kidney Foundation Conference; 2011
48. Besarab A, Chernyavskaya EN, Motylev I, et al. FG-4592, an oral hypoxia-inducible factor propyl hydroxylase inhibitor, corrects anemia without iron supplementation in incident dialysis patients. J Am Soc Nephrol 2012;23:abstract 21A
49. Besarab A, Tak Mao Chan D, Dua SL, et al. Hypoxia inducing factor propyl hydroxylase inhibitor FG-4592 corrects anemia in peritoneal dialysis. J Am Soc Nephrol 2013;24:abstract 91A 50. Available from: Http://clinicaltrials.gov/ ct2/results?term=AKB-6548+&Search=Search [Last accessed 15 October 2013]
50. Available from: Http://www.businesswire. com/news/home/20120405005347/en/ Akebia-Meets-Primary-Endpoint-Phase-2-Study [Last accessed 15 October 2013]
51. Available from: Http://www.pharmabiz. com/NewsDetails.aspx?aid= 76706&sid=2 [Last accessed 15 October 2013]
52. Okumura CY, Hollands A, Tran DN, et al. A new pharmacological agent (AKB-4924) stabilizes hypoxia inducible factor-1 (HIF-1) and increases skin innate defenses against bacterial infection. J Mol Med (Berl) 2012;90(9):1079-89
53. Available from: Http://www.gskclinicalstudyregister. com/ result-comp-list.jsp? compound=GSK1278863 [Last accessed 15 October 2013]
54. Available from: Http://clinicaltrials.gov/ ct2/show/NCT01406340? term=GSK1278863&rank=7 [Last accessed 15 October 2013]
55. Available from: Http://www.gskclinicalstudyregister. com/result-detail. jsp? protocolId=114272&studyId=06119F41-7DBB-405A-BC61-B2AF91 3A328C&compound=GSK1278863 [Last accessed 15 October 2013]
56. Available from: Http://clinicaltrials.gov/ ct2/show/NCT01831804? term=GSK1278863&rank=6 [Last accessed 15 October 2013]
57. Boettcher MF, Lentini S, Kaiser A, et al. First-in-man studt with BAY 85-3934-A new oral selective HIF-PH inhibitor for the treatment of oral anemia [abstract]. J Am Soc Nephrol 2013;24:347a
58. Pfeffer MA, Burdmann EA, Chen CY, et al.; TREAT investigators. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med 2009;361(21):2019-32
59. Locatelli F, Andrulli S, Memoli B, et al. Nutritional-inflammation status and resistance to erythropoietin therapy in haemodialysis patients. Nephrol Dial Transplant 2006;21(4):991-8
60. Locatelli F, Aljama P, Canaud B, et al.; Anaemia Working Group of European Renal Best Practice (ERBP). Target haemoglobin to aim for with erythropoiesis-stimulating agents: A position statement by ERBP following publication of the trial to reduce cardiovascular events with aranesp therapy (TREAT) study. Nephrol Dial Transplant 2010;25(9):2846-50
61. Locatelli F, Bárány P, Covic A, et al.; ERA-EDTA ERBP Advisory Board. Kidney disease: Improving global outcomes guidelines on anaemia management in chronic kidney disease: A european renal best practice position statement. Nephrol Dial Transplant 2013;28(6):1346-59
62. Xu Y, Ding XQ, Zou JZ, et al. Serum hepcidin in haemodialysis patients: Associations with iron status and microinflammation. J Int Med Res 2011;39(5):1961-7
63. Kuragano T, Itoh K, Shimonaka Y, et al. Hepcidin as well as TNF-Alpha are significant predictors of arterial stiffness in patients on maintenance hemodialysis. Nephrol Dial Transplant 2011;26(8):2663-7
64. Hsieh YP, Huang CH, Lee CY, et al. Hepcidin-25 negatively predicts left ventricular mass index in chronic kidney disease patients. World J Nephrol 2013;2(2):38-43
65. Nakanishi T, Hasuike Y, Otaki Y, et al. Hepcidin: Another culprit for complications in patients with chronic kidney disease? Nephrol Dial Transplant 2011;26(10):3092-100