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. 2014 May 28;2014(5):CD003895. doi: 10.1002/14651858.CD003895.pub3

Lee 2008.

Methods
  • Study design: open‐label, parallel RCT

  • Study duration: July 2004 to April 2005

  • Duration of follow‐up: 12 weeks

Participants
  • Country: Korea

  • Setting: multicentre

  • Regular HD ≥ 3 months; age ≥18 years; stable EPO dose 3000 to 12,000 U/wk. Hb 9 to 12 g/dL; stable iron stores

  • Number: treatment group 1 (44); treatment group 2 (39)

  • Mean age ± SD (years): treatment group 1 (55.7 ± 10.1); treatment group 2 (53.3 ± 12.9)

  • Sex (M/F): treatment group 1 (24/20); treatment group 2 (23/16)

  • Exclusion criteria: uncontrolled HT; DBP ≥110 mm Hg; hyperparathyroidism ≥ 800 pg/mL; acute infection/inflammation; severe CCF; GI bleed; pregnancy; immunosuppressive or androgen therapy; malignancy; epilepsy; transfused ≤ 2 months previous; sensitivity to EPO

Interventions Treatment group 1
  • EPO: SC once/wk for 12 weeks

  • Starting dose previous total weekly dose


Treatment group 2
  • EPO: SC 2 to 3 times/wk for 12 weeks

  • Continue previous dose


Other information
  • Type of ESA: EPO alfa

  • Dose adjusted in both groups to maintain Hb level at 9 to 12.0 g/dL


Co‐interventions
  • All received IV iron therapy

Outcomes
  • Final Hb at 12 weeks

  • Mean EPO dose at week 10

  • Proportion of patients keeping a stable Hb level

  • Adverse effects

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information about sequence generation process to permit judgement
Allocation concealment (selection bias) Low risk Randomised by central randomisation. Stratified for EPO dose
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Open‐label study but primary outcome was laboratory measure and unlikely to be subject to bias
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Open‐label study but primary outcome was laboratory measure and unlikely to be subject to bias
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Reported ITT and PP data. Loss to follow‐up/withdrawal post randomisation: 4 in each group (protocol violation; dose change in study period; Hb ≥ 12 at randomisation). Loss to follow‐up unlikely to influence results
Selective reporting (reporting bias) High risk No information on mortality and incomplete information on adverse effects
Other bias High risk Supported/funded by LG Life Sciences Co Ltd