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Table 2 Summary of the studies included in the systematic review

From: Efficacy and safety data of subsequent entry biologics pertinent to nephrology practice: a systematic review

Authors (year) Design Population Enrolment Intervention Follow-up Outcomes
HX 575
Haag-Weber et al. 2009 [15] R DB multicentre parallel group equivalence study HD patients I: 314 C: 164 HX 575 vs. Epoetin alpha IV at a 1:1 dose conversion 56 weeks 1: Occurrence of anti-Epoetin Abs and the evaluations of ADR
Haag-Weber et al. 2012 [16] RCT DB CKD Stage 3-4 I: 175 C: 163 HX 575 SC 75 IU/kg/week vs. Epoetin alpha SC 75 IU/kg/week 26 weeks 1: Occurrence of anti-Epoetin Abs and the evaluations of ADRs
Stopped early due to safety issue
Horl et al. 2012 [17] Multicentre prospective single arm study CKD patients on dialysis or not I: 745 HX 575 IV 3 times/week 26 weeks 1: Occurrence of anti-Epoetin Abs and the evaluations of ADRs
Epoetin zeta
Baldamus et al. 2008 [12] Multicentre non-controlled, follow-up HD patients I:745 Epoetin zeta IV 1–3 times/week 56 weeks (108 weeks for Bulgarian subgroup) 1: Occurrence of anti-Epoetin Abs and the evaluations of ADRs
Krivoshiev et al. 2008 [8] RCT DB multicentre HD patients I:305 C:304 Epoetin zeta IV 1–3 times/week vs. Epoetin alpha IV 1–3 times/week 24 weeks 1: Dose of epoetin/kg /week; Hb during the last 4 weeks of treatment; proportion of patients with treatment success, increase in Hb over time, proportion of patients with maintenance success, Hb during each 4-week interval, proportion of patients with an increase in Hb of > 1 g/dL for 4 weeks, percentage of Hb > 10 g/dL, percentage of HCT measurements > 30%, proportion of patients needing blood transfusion
Krivoshiev et al. 2010 [9] RCT DB multicentre HD patients I: 232 C: 230 Epoetin zeta SC vs. Epoetin alpha SC 28 weeks 1: Dose of epoetin/kg/week; Hb during the last 4 weeks of treatment; mean HCT; proportion of patients with any permanent or transient changes in Hb > 1 g/dL; proportion of patients with any permanent or transient dose change; proportion of patients with any Hb outside the target range; incidence of blood transfusion
Lonneman et al. 2011 [10] Observational single centre HD patients I: 18 Epoetin zeta IV 26 weeks 1: Dose of epoetin/kg/week ;Hb during the last 4 weeks of treatment; incidence of Hb > 13 g/dL, the ratings of local and general tolerability, the occurrence of anti-EPO Abs and evaluation of ADRs
Wizemann et al. 2008 [11] DB cross-over study multicentre HD patients I: 155 C:158 Epoetin zeta IV 1–3 times/week and Epoetin alpha IV 1–3 times/week 12 weeks x 2 1: Dose of epoetin/kg/week; Hb during the last 4 weeks of treatment; HCT levels; proportion of patients with any permanent or transient changes in Hb > 1 g/dL; proportion of patients with any permanent or transient dose change; proportion of patients with any Hb measurement outside the target range; incidence of blood transfusion
Epoetin theta
Gertz et al. 2010 [18] Multicentre DB parallel-group non-inferiority controlled trial HD patients I:180 C: 90 Epoetin theta IV vs. Epoetin beta IV; 1:1 dosage conversion 26 weeks 1: Change in Hb from baseline to end of treatment
Gertz et al. 2012 [19] Multicentre DB parallel-group non-inferiority controlled trial CKD Stage 3–5 non on dialysis I: 193 C: 95 Epoetin theta SC 1 time/week vs. Epoetin beta SC 1 time/week 26 weeks 1: Change in Hb from baseline to end of treatment
  1. R = randomized; DB = double-blind; HD = hemodialysis; I = Intervention; C = Control; IV = intravenous; SC = subcutaneous; 1: Study primary outcome; Abs = Antibodies; ADRs = Adverse drug reactions; RCT = Randomized controlled trial; CKD = Chronic kidney disease; Hb = haemoglobin; HCT = Hematocrit.