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

  • Study duration: NS

Participants
  • Setting: multicentre

  • Country: The Netherlands

  • Stage of CKD: eGFR 20 to 70 mL/min/1.73 m²

  • Number: epoetin beta (20), no treatment (13)

  • Median age, IQR (years): epoetin beta (77, 70 to 81), no treatment (72, 64 to 67 (error in paper))

  • Sex (M/F): epoetin beta (12/8), no treatment (9/4)

  • Other characteristics: cardiorenal syndrome with chronic heart failure, CKD and anaemia; anaemia was defined as Hb between 10.3 and 12.6 g/dL in men and between 10.3 and 11.9 g/dL in women

  • Exclusion criteria: Erythropoietic therapy within 6 months before randomisation; uncontrolled hypertension (SBP > 160 mm Hg; DBP > 100 mm Hg); uncontrolled diabetes (HbA1c > 8.0%); kidney transplantation; proteinuria > 3.5 g/L; acute kidney failure or rapidly progressive glomerulonephritis; hyperparathyroidism (PTH > 40 pmol/L); haemoglobinopathies; bleeding or haemolysis as a cause of anaemia; deficiency of iron; folate and/or vitamin B12; chronic inflammatory disease or clinically significant infection; haematological malignancy or solid tumour < 3 years ago

Interventions Treatment
  • Epoetin beta

    • 50 IU/kg/wk for 6 months


Control
  • No treatment for 6 months


Iron supplementation
  • Oral

Outcomes Primary study outcome
  • Hepcidin levels


Outcomes extracted for meta‐analysis
  • All‐cause mortality

  • Major cardiovascular events

  • Stroke

  • ESKD

Notes
  • Funding: F. Hoffman‐La Roche

  • Trials registration: NCT00356733

  • Contact with study authors for additional information: contacted, additional information provided by sponsor

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 randomised trial"
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not described
Incomplete outcome data (attrition bias) All outcomes Unclear risk Not described
Selective reporting (reporting bias) Low risk Major cardiovascular outcomes available
Other bias Low risk None apparent;