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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.