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. 2022 Apr 1;17(4):e0266243. doi: 10.1371/journal.pone.0266243

Table 1. Characteristics of the included studies.

Author, year Location (sites number) Study design Study period Groups Number of patients Age in years, Mean ± SD Male ratio, % Roxadustat dose Study duration Phase
Akizawa et al. 2019 [32] Japan (32) Double-blinded RCT 2013–2015 Roxadustat 80 64.4 ± 8.7 48.80% (50 mg,70 mg, and 100 mg) TIW 24 weeks 2
Placebo 27 61.9 ± 10.6 40.70%
Akizawa et al. 2021 [14] Japan (71) Open-label RCT 2017–2020 Roxadustat 131 68.9 ± 11.6 63.40% (70mg or 100mg) TIW 52 weeks 3
DA 131 70.9 ± 10.2 57.30%
Barratt et al. 2021 [15] Europe (200) Open-label RCT 2014–2018 Roxadustat 323 66.8 ± 13.6 44.90% (Weight 45 to 70 kg, 70 mg; weight >70 to 160 kg, 100 mg) TIW 104 weeks 3
DA 293 65.7 ± 14.4 44%
Besarab et al. 2015 [33] United States (29) Single-blind RCT 2008–2010 Roxadustat 88 64 37.50% (0.7, 1, 1.5 or 2 mg/kg) BIW or TIW 4 weeks 2a
Placebo 28 68.6 57.10%
Chen et al. 2017 [29] China (11) Double-blinded RCT 2011–2012 Roxadustat 61 48.9 ± 13.8 29.50% low (1.1–1.75 mg/kg) or high (1.50–2.25 mg/kg) TIW 8 weeks 2
Placebo 30 51.4 ± 11.9 26.70%
Chen et al. 2019 [30] China (29) Double-blinded RCT 2015–2016 Roxadustat 101 54.7 ± 13.3 36% (Weight 40 to <60 kg, 70mg; weight ≥60 kg, 100mg) TIW 8 weeks 3
Placebo 51 53.2 ± 13.1 39%
Coyne et al. 2021 [28] United States, South America, Australia, New Zealand, and Asia (163) Double-blinded RCT 2012–2018 Roxadustat 616 64.9 ± 12.6 39.10% (Weight 45 to <70 kg, 70mg; weight ≥70 kg, 100mg) TIW 28–52 weeks 3
Placebo 306 64.8 ± 13.2 43.50%
Fishbane et al. 2021 [34] 25 Countries (385) Double-blinded RCT 2014–2018 Roxadustat 1384 60.9 ± 14.7 40.80% 70mg TIW 28–52 weeks 3
Placebo 1377 62.4 ± 14.1 43.80%
Shutov et al. 2021 [16] Different countries, mainly from Europe (138) Double-blinded RCT 2013–2017 Roxadustat 391 58.25 ± 19.91 43.20% (Weight 45 to ≤70 kg, 70mg; weight >70 to ≤ 160 kg, 100mg) TIW 52–104 weeks 3
Placebo 203 60.5 ± 18.46 48.80%

Continuous variables are expressed in mean ± standard deviation.

RCT = randomized control trial; DA = darbepoetin alfa; TIW = three times a week; DIW = two times a week; SD: standard deviation.