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

  • Study duration: NS

Participants
  • Setting: University of Skopje

  • Country: Macedonia

  • Stage of CKD: HD

  • Number: epoetin beta (19), no treatment (19)

  • Mean age; range (years): epoetin beta (47.6; 25 to 70), no treatment (48.3; 23 to 69)

  • Sex (M/F): epoetin beta (10/9), placebo (11/8)

  • Other characteristics: anaemia (HCT< 28%) or need for regular blood transfusions; adequate iron status

  • Exclusion criteria: iron, folic acid or vitamin B12 deficiency; severe infection; malignant or systematic disease; acute liver infection; uncontrolled hypertension; epilepsy; pregnancy; haemolytic uraemic syndrome; thrombocytosis (> 500,000 mm³)

Interventions Treatment group
  • Epoetin beta

    • SC to attain HCT 30% to 35% for 12 months


Control group
  • No treatment


Iron supplementation
  • NS

Outcomes Primary trial outcome
  • Left ventricular hypertrophy at 12 months


Outcomes extracted for meta‐analysis
  • None

Notes
  • Funding: Boehringer Mannheim

  • Trials registration: not applicable

  • Contact with authors: not contacted

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 described
Incomplete outcome data (attrition bias) All outcomes Low risk 2/40 lost to follow‐up (5%). As this was < 10% this was judged low risk
Selective reporting (reporting bias) High risk Data for cardiovascular events not available
Other bias Low risk None apparent