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 | 56Â 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 75Â IU/kg/week vs. Epoetin alpha SC 75Â IU/kg/week | 26Â 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 | 26Â 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 | 26Â 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 |