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.