Skip to main content
. 2014 Dec 8;2014(12):CD010590. doi: 10.1002/14651858.CD010590.pub2
Methods
  • Study design: RCT

  • Study duration: NS

Participants
  • Setting: single centre

  • Country: Taiwan

  • Stage of CKD: PD

  • Number: epoetin alfa (23), darbepoetin alfa (22)

  • Mean age ± SD (years): epoetin alfa (48.0 ± 11.15), darbepoetin alfa (49.5 ± 9.75)

  • Sex (M/F): epoetin alfa (8/15), darbepoetin alfa (12/10)

  • Other characteristics: existing epoetin therapy; adequate iron stores

  • Exclusion criteria: receiving treatment for grand mal epilepsy or had uncontrolled hypertension (DBP > 100 mm Hg); congestive heart failure (New York Heart Association class III or IV); clinical evidence of severe hyperparathyroidism (iPTH ≥ 800 pg/mL); haematologic or systemic infection or inflammatory disease; current active liver disease; current active peritonitis; current malignancy that might interfere with the erythropoietic response; psychiatric, addictive, or any disorder that compromised the ability to give informed consent for participation in this study were also excluded; pregnant or breast‐feeding women; RBC transfusion to treat anaemia within 1 month prior to enrolment; major surgery or androgen therapy within 3 months prior to enrolment in the study

Interventions Treatment group
  • Epoetin alfa

    • SC aiming for Hb level maintained within a target range of ± 1.0 g/dL of their baseline Hb level between 9.5 to 12.5 g/dL for 6 months


Control group
  • Darbepoetin alfa

    • SC aiming for Hb level maintained within a target range of ± 1.0 g/dL of their baseline Hb level between 9.5 to 12.5 g/dL for 6 months


Iron supplementation
  • IV

Outcomes Primary trial outcome
  • Mean change in Hb level between the screening/baseline and evaluation period


Outcomes extracted for meta‐analysis
  • All‐cause mortality

Notes
  • Funding: Kirin Pharmaceutical

  • Trials registration: NS

  • Contact with authors: contacted (no reply or data received)

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias) All outcomes High risk Open‐label
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) All outcomes High risk 4/23 lost from epoetin alfa arm (17%) and 4/22 lost from darbepoetin alfa arm (17%). As this was > 10% this was judged as high risk
Selective reporting (reporting bias) High risk Data for cardiovascular outcomes not available
Other bias Low risk None apparent