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

Carrera 2003.

Methods

  • Study design: parallel RCT

  • Time frame: NS

  • Duration of follow‐up: 10 months
Participants

  • Country: Portugal

  • Setting: single centre

  • Age: ≥18 years; HD; 6 months on IV rHuEPO; Hb stable 11.0 to 12.5 g/dL

  • Number (completed/evaluated): treatment group 1 (18/24); treatment group 2 (13/20)

  • Mean age ± SD (years): treatment group 1 (57.7 ± 11.78); treatment group 2 (61.5 ± 22.6)

  • Sex (M/F): treatment group 1 (16/2); treatment group 2 (7/6)

  • Exclusion criteria: no active bleeding, infection or inflammation
Interventions Treatment group 1

  • DA: IV weekly for 10 months

  • Dose calculated according to previous dose when 200 IU EPO = 1 μg DA

  • Dose at baseline: 35.70 µg/wk (95% CI 26.90 to 47.40)


Treatment group 2

  • rHuEPO: IV 3 times/wk for 10 months

  • Continued previous dose

  • Dose at baseline: 5837 IU/wk (95% CI 3670 to 9281 IU/wk)

  • Doses of EPO and DA were titrated to maintain Hb in the range 11.0 to 12.5 g/dL


Co‐interventions

  • Iron supplements as necessary
Outcomes

  • Hb at end of study

  • Change in Hb

  • ESA dose at end of study

  • Iron parameters at end of study

  • Adverse effects
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study stated to be randomised but no other information provided: "randomised study"
Allocation concealment (selection bias) Unclear risk Study stated to be randomised but no other information provided
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Primary outcome was laboratory based and not likely to be influenced by blinding. Study participants and personnel not blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Primary outcome was laboratory based and not likely to be influenced by blinding. Study participants and personnel not blinded
Incomplete outcome data (attrition bias) 
 All outcomes High risk Data only reported on patients, who completed study. 13 (29.5%) did not complete the study; DA group: died (2), transplants (2), surgery (2); rHuEPO group: died (3), transplant (1), surgery (3)
Selective reporting (reporting bias) Low risk Study protocol not available but published results include all expected outcomes
Other bias Unclear risk Funding: NS