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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: Cardiac division, “Le Scotte” Hospital, University of Siena

  • Country: Italy

  • Stage of CKD: mild to moderate kidney disease (eGFR 30 to 60 mL/min)

  • Number: epoetin beta (28), placebo (28)

  • Mean age ± SD (years): epoetin beta (74 ± 6), placebo (72 ± 6)

  • Sex (M/F): epoetin beta (15/11), placebo (16/9)

  • Other characteristics: adults with history of moderate or severe CHF (NYHA III or IV) with systolic dysfunction (LVEF < 40%), and Hb < 11.5 g/dL; no secondary cause of anaemia

  • Exclusion criteria: patients with isolated diastolic dysfunction, valvular disease, recent myocardial infarction (within 12 weeks); severe hypertension; gastrointestinal bleeding; secondary causes of anaemia including hypothyroidism, folic acid, and vitamin B12 deficiency

Interventions Treatment group
  • Epoetin beta

    • SC 6000 IU twice/wk


Control group
  • Placebo

    • SC 6000 IU twice/wk


Iron supplementation
  • Oral ferrous gluconate 300 mg/d

Outcomes Primary trial outcome
  • Left ventricular dimension and function


Outcome extracted for meta‐analysis
  • All‐cause mortality

Notes
  • Funding: NS

  • Trials registration: NS

  • 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 Low risk Double‐blind placebo controlled
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not described for all‐cause mortality
Incomplete outcome data (attrition bias) All outcomes Low risk 5/56 lost to follow‐up and reasons given (< 10%)
Selective reporting (reporting bias) High risk No data for cardiovascular events extractable for analysis
Other bias Low risk None apparent