1. Zhang L, Wang F, Wang L, et al. Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet 2012;379:815–822.
2. Stauffer ME, Fan T. Prevalence of anemia in chronic kidney disease in the United States. PLoS One 2014;9:e84943.
3. Smith RE Jr.. The clinical and economic burden of anemia. Am J Manag Care 2010;16:Suppl Issues. S59–S66.
4. Souaid T, Taliercio J, Simon JF, Mehdi A, Nakhoul GN. Anemia of chronic kidney disease: will new agents deliver on their promise? Cleve Clin J Med 2022;89:212–222.
5. Horl WH. Anaemia management and mortality risk in chronic kidney disease. Nat Rev Nephrol 2013;9:291–301.
6. Benz R, Schmidt R, Kelly K, Wolfson M. Epoetin alfa once every 2 weeks is effective for initiation of treatment of anemia of chronic kidney disease. Clin J Am Soc Nephrol 2007;2:215–221.
7. Seliger S, Fox KM, Gandra SR, et al. Timing of erythropoiesis-stimulating agent initiation and adverse outcomes in nondialysis CKD: a propensity-matched observational study. Clin J Am Soc Nephrol 2010;5:882–888.
8. Agarwal R, Kusek JW, Pappas MK. A randomized trial of intravenous and oral iron in chronic kidney disease. Kidney Int 2015;88:905–914.
9. Macdougall IC, White C, Anker SD, et al. Intravenous iron in patients undergoing maintenance hemodialysis. N Engl J Med 2019;380:447–458.
10. Sakaguchi Y, Hamano T, Wada A, Masakane I. Types of erythropoietin-stimulating agents and mortality among patients undergoing hemodialysis. J Am Soc Nephrol 2019;30:1037–1048.
11. Kaplan JM, Sharma N, Dikdan S. Hypoxia-inducible factor and its role in the management of anemia in chronic kidney disease. Int J Mol Sci 2018;19:389.
12. Semenza GL, Agani F, Booth G, et al. Structural and functional analysis of hypoxia-inducible factor 1. Kidney Int 1997;51:553–555.
13. Peyssonnaux C, Nizet V, Johnson RS. Role of the hypoxia inducible factors HIF in iron metabolism. Cell Cycle 2008;7:28–32.
14. Pergola PE, Spinowitz BS, Hartman CS, Maroni BJ, Haase VH. Vadadustat, a novel oral HIF stabilizer, provides effective anemia treatment in nondialysis-dependent chronic kidney disease. Kidney Int 2016;90:1115–1122.
15. Meadowcroft AM, Cizman B, Holdstock L, et al. Daprodustat for anemia: a 24-week, open-label, randomized controlled trial in participants on hemodialysis. Clin Kidney J 2019;12:139–148.
16. Holdstock L, Cizman B, Meadowcroft AM, et al. Daprodustat for anemia: a 24-week, open-label, randomized controlled trial in participants with chronic kidney disease. Clin Kidney J 2019;12:129–138.
17. Akizawa T, Macdougall IC, Berns JS, et al. Long-term efficacy and safety of molidustat for anemia in chronic kidney disease: DIALOGUE Extension Studies. Am J Nephrol 2019;49:271–280.
18. Parmar DV, Kansagra KA, Patel JC, et al. Outcomes of desidustat treatment in people with anemia and chronic kidney disease: a phase 2 study. Am J Nephrol 2019;49:470–478.
19. Chen N, Hao C, Peng X, et al. Roxadustat for anemia in patients with kidney disease not receiving dialysis. N Engl J Med 2019;381:1001–1010.
20. Chen N, Hao C, Liu BC, et al. Roxadustat treatment for anemia in patients undergoing long-term dialysis. N Engl J Med 2019;381:1011–1022.
21. Nangaku M, Kojima I, Tanaka T, Ohse T, Kato H, Fujita T. Novel drugs and the response to hypoxia: HIF stabilizers and prolyl hydroxylase. Recent Pat Cardiovasc Drug Discov 2006;1:129–139.
22. Provenzano R, Besarab A, Wright S, et al. Roxadustat (FG-4592) versus epoetin alfa for anemia in patients receiving maintenance hemodialysis: a phase 2, randomized, 6- to 19-week, open-label, active-comparator, dose-ranging, safety and exploratory efficacy study. Am J Kidney Dis 2016;67:912–924.
23. Provenzano R, Besarab A, Sun CH, et al. Oral hypoxia-inducible factor prolyl hydroxylase inhibitor roxadustat (FG-4592) for the treatment of anemia in patients with CKD. Clin J Am Soc Nephrol 2016;11:982–991.
24. Besarab A, Provenzano R, Hertel J, et al. Randomized placebo-controlled dose-ranging and pharmacodynamics study of roxadustat (FG-4592) to treat anemia in nondialysis-dependent chronic kidney disease (NDD-CKD) patients. Nephrol Dial Transplant 2015;30:1665–1673.
25. Wang GL, Jiang BH, Rue EA, Semenza GL. Hypoxia-inducible factor 1 is a basic-helix-loop-helix-PAS heterodimer regulated by cellular O2 tension. Proc Natl Acad Sci U S A 1995;92:5510–5514.
26. Semenza GL. Hypoxia-inducible factor 1: master regulator of O2 homeostasis. Curr Opin Genet Dev 1998;8:588–594.
27. Zhang W, Gong Z, Peng X, Tang S, Bi M, Huang W. Clinical characteristics and outcomes of rural patients with ESRD in Guangxi, China: one dialysis center experience. Int Urol Nephrol 2010;42:195–204.
28. Eschbach JW, Abdulhadi MH, Browne JK, et al. Recombinant human erythropoietin in anemic patients with end-stage renal disease: results of a phase III multicenter clinical trial. Ann Intern Med 1989;111:992–1000.
29. Mocks J. Cardiovascular mortality in haemodialysis patients treated with epoetin beta: a retrospective study. Nephron 2000;86:455–462.
30. Drueke TB, Locatelli F, Clyne N, et al. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med 2006;355:2071–2084.
31. Singh AK, Szczech L, Tang KL, et al. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 2006;355:2085–2098.
32. Pfeffer MA, Burdmann EA, Chen CY, et al. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med 2009;361:2019–2032.
33. Szczech LA, Barnhart HX, Inrig JK, et al. Secondary analysis of the CHOIR trial epoetin-alpha dose and achieved hemoglobin outcomes. Kidney Int 2008;74:791–798.
34. Solomon SD, Uno H, Lewis EF, et al. Erythropoietic response and outcomes in kidney disease and type 2 diabetes. N Engl J Med 2010;363:1146–1155.
35. Chan AW, Tetzlaff JM, Gotzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586.
36. Locatelli F, Fishbane S, Block GA, Macdougall IC. Targeting hypoxia-inducible factors for the treatment of anemia in chronic kidney disease patients. Am J Nephrol 2017;45:187–199.
37. Akizawa T, Iwasaki M, Yamaguchi Y, Majikawa Y, Reusch M. Phase 3, randomized, double-blind, active-comparator (darbepoetin alfa) study of oral roxadustat in CKD patients with anemia on hemodialysis in Japan. J Am Soc Nephrol 2020;31:1628–1639.
38. Johnson DW, Pollock CA, Macdougall IC. Erythropoiesis-stimulating agent hyporesponsiveness. Nephrology (Carlton) 2007;12:321–330.
39. Rizzo JD, Somerfield MR, Hagerty KL, et al. Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update. J Clin Oncol 2008;26:132–149.
40. Gomes AC, Gomes MS. Hematopoietic niches, erythropoiesis and anemia of chronic infection. Exp Hematol 2016;44:85–91.
41. Bradbury BD, Critchlow CW, Weir MR, Stewart R, Krishnan M, Hakim RH. Impact of elevated C-reactive protein levels on erythropoiesis-stimulating agent (ESA) dose and responsiveness in hemodialysis patients. Nephrol Dial Transplant 2009;24:919–925.
42. Amparo FC, Kamimura MA, Molnar MZ, et al. Diagnostic validation and prognostic significance of the Malnutrition-Inflammation Score in nondialyzed chronic kidney disease patients. Nephrol Dial Transplant 2015;30:821–828.
43. Oberg BP, McMenamin E, Lucas FL, et al. Increased prevalence of oxidant stress and inflammation in patients with moderate to severe chronic kidney disease. Kidney Int 2004;65:1009–1016.
44. Besarab A, Chernyavskaya E, Motylev I, et al. Roxadustat (FG-4592): correction of anemia in incident dialysis patients. J Am Soc Nephrol 2016;27:1225–1233.
45. Ganz T, Nemeth E. Hepcidin and iron homeostasis. Biochim Biophys Acta 2012;1823:1434–1443.
46. Fishbane S, Pollock CA, El-Shahawy M, et al. Roxadustat versus epoetin alfa for treating anemia in patients with chronic kidney disease on dialysis: results from the randomized phase 3 ROCKIES study. J Am Soc Nephrol 2022;33:850–866.
47. Csiky B, Schomig M, Esposito C, et al. Roxadustat for the maintenance treatment of anemia in patients with end-stage kidney disease on stable dialysis: a European phase 3, randomized, open-label, active-controlled study (PYRENEES). Adv Ther 2021;38:5361–5380.
48. Provenzano R, Shutov E, Eremeeva L, et al. Roxadustat for anemia in patients with end-stage renal disease incident to dialysis. Nephrol Dial Transplant 2021;36:1717–1730.
49. Charytan C, Manllo-Karim R, Martin ER, et al. A randomized trial of roxadustat in anemia of kidney failure: SIERRAS study. Kidney Int Rep 2021;6:1829–1839.
50. Groenendaal-van de Meent D, Kerbusch V, Kaspera R, et al. Effect of kidney function and dialysis on the pharmacokinetics and pharmacodynamics of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor. Eur J Drug Metab Pharmacokinet 2021;46:141–153.
51. Akizawa T, Otsuka T, Reusch M, Ueno M. Intermittent oral dosing of roxadustat in peritoneal dialysis chronic kidney disease patients with anemia: a randomized, phase 3, multicenter, open-label study. Ther Apher Dial 2020;24:115–125.
52. Chen N, Qian J, Chen J, et al. Phase 2 studies of oral hypoxia-inducible factor prolyl hydroxylase inhibitor FG-4592 for treatment of anemia in China. Nephrol Dial Transplant 2017;32:1373–1386.
53. Hou YP, Mao XY, Wang C, et al. Roxadustat treatment for anemia in peritoneal dialysis patients: a randomized controlled trial. J Formos Med Assoc 2022;121:529–538.
54. Wu T, Qi Y, Ma S, et al. Efficacy of roxadustat on anemia and residual renal function in patients new to peritoneal dialysis. Ren Fail 2022;44:529–540.
55. Chen J, Li Z, Zhang H, et al. A prospective, self-controlled pilot study of the efficacy of roxadustat for erythropoietin hyporesponsiveness in patients requiring chronic ambulatory peritoneal dialysis. J Ren Nutr 2022;32:595–604.
56. Yang Z, Ma T, Xu X, et al. Randomized study on the efficacy of standard versus low roxadustat dose for anemia in patients on peritoneal dialysis. Kidney Int Rep 2021;7:455–464.
57. Nemeth E, Ganz T. Regulation of iron metabolism by hepcidin. Annu Rev Nutr 2006;26:323–342.
58. Peyssonnaux C, Zinkernagel AS, Schuepbach RA, et al. Regulation of iron homeostasis by the hypoxia-inducible transcription factors (HIFs). J Clin Invest 2007;117:1926–1932.
59. Nguyen AD, McDonald JG, Bruick RK, DeBose-Boyd RA. Hypoxia stimulates degradation of 3-hydroxy-3-methylglutaryl-coenzyme A reductase through accumulation of lanosterol and hypoxia-inducible factor-mediated induction of insigs. J Biol Chem 2007;282:27436–27446.
60. Hwang S, Nguyen AD, Jo Y, Engelking LJ, Brugarolas J, De-Bose-Boyd RA. Hypoxia-inducible factor 1α activates insulin-induced gene 2 (Insig-2) transcription for degradation of 3-hydroxy-3-methylglutaryl (HMG)-CoA reductase in the liver. J Biol Chem 2017;292:9382–9393.
61. Ku E, Campese V. Is lipid management effective for all stages of CKD? Blood Purif 2013;35:26–30.
62. Anker MS, Butler J, Anker SD. Roxadustat for anemia in patients with chronic kidney disease. N Engl J Med 2020;383:e3.
63. Liu J, Zhang A, Hayden JC, et al. Roxadustat (FG-4592) treatment for anemia in dialysis-dependent (DD) and not dialysis-dependent (NDD) chronic kidney disease patients: a systematic review and meta-analysis. Pharmacol Res 2020;155:104747.
64. Shutov E, Sulowicz W, Esposito C, et al. Roxadustat for the treatment of anemia in chronic kidney disease patients not on dialysis: a phase 3, randomized, double-blind, placebo-controlled study (ALPS). Nephrol Dial Transplant 2021;36:1629–1639.
65. Fishbane S, El-Shahawy MA, Pecoits-Filho R, et al. Roxadustat for treating anemia in patients with CKD not on dialysis: results from a randomized phase 3 study. J Am Soc Nephrol 2021;32:737–755.
66. Coyne DW, Roger SD, Shin SK, et al. Roxadustat for CKD-related anemia in non-dialysis patients. Kidney Int Rep 2020;6:624–635.
67. Barratt J, Andric B, Tataradze A, et al. Roxadustat for the treatment of anaemia in chronic kidney disease patients not on dialysis: a phase 3, randomized, open-label, active-controlled study (DOLOMITES). Nephrol Dial Transplant 2021;36:1616–1628.
68. Rowland Yeo K, Aarabi M, Jamei M, Rostami-Hodjegan A. Modeling and predicting drug pharmacokinetics in patients with renal impairment. Expert Rev Clin Pharmacol 2011;4:261–274.
69. Nolin TD, Frye RF, Matzke GR. Hepatic drug metabolism and transport in patients with kidney disease. Am J Kidney Dis 2003;42:906–925.
70. Abdelazeem B, Shehata J, Abbas KS, et al. The efficacy and safety of roxadustat for the treatment of anemia in non-dialysis dependent chronic kidney disease patients: an updated systematic review and meta-analysis of randomized clinical trials. PLoS One 2022;17:e0266243.
71. Goel HL, Mercurio AM. VEGF targets the tumour cell. Nat Rev Cancer 2013;13:871–882.
72. Krock BL, Skuli N, Simon MC. Hypoxia-induced angiogenesis: good and evil. Genes Cancer 2011;2:1117–1133.
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