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

Mircescu 2006.

Methods
  • Study design: parallel RCT

  • Duration of study: 1 March 2004 to 31 January 2005

  • Duration of follow‐up: 24 weeks

Participants
  • Country: Romania

  • Setting: multicentre

  • HD 6 months (Kt/v 1.2); Hb > 10 g/dL; adequate iron stores; ferritin 100 to 88 ng/mL; TSAT 20 to 50%; once weekly SC EPO for 2 months before enrolment ≥ 18 years

  • Number: treatment group 1 (104); treatment group 2 (103)

  • Mean age ± SD (years): treatment group 1 (49.6 ± 13.3); treatment group 2 (48.0 ± 12.9)

  • Sex (M/F): treatment group 1 (57/47); treatment group 2 (62/41)

  • Exclusion criteria: CHF; hepatic disease; CRP > 12 mg/L; severe hyperparathyroidism (PTH > 800 ng/mL); serum B₁₂ or folate deficiency; poor BP control; malnutrition; albumin < 40 g/L; blood transfusions in last 2 months

Interventions Treatment group 1
  • rHuEPO: SC every 2 weeks, same cumulative dose administered every other week for 24 weeks


Treatment group 2
  • rHuEPO SC once/wk, continued the previous once weekly schedule


Other information
  • Dose adjustments were made to maintain Hb levels in both groups


Co‐interventions
  • Iron therapy was continued according to Romanian Best Practice Guidelines

Outcomes
  • Final or change in Hb

  • Number reaching target HB

  • Change in median EPO dose

  • Adverse events

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Renal Registry Romania. Numbered containers
Allocation concealment (selection bias) Low risk Central randomisation. Renal Registry Romania
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk No blinding but outcome of Hb unlikely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk No blinding but outcome of Hb unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 4/207 excluded from analyses (4 withdrew after randomisation (2 from each group)), unlikely to influence results
Selective reporting (reporting bias) High risk No information on mortality
Other bias High risk Funding for laboratory tests from F. Hoffman la Roche Ltd