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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: Multicentre, long‐term care facilities

  • Country: USA

  • Stage of CKD: Stage 3, 4, or 5 (not on dialysis), eGFR < 60 mL/min/1.73 m², and a stable creatinine over the past 3 months, or CKD Stage 2, GFR 61 to 90 mL/ min/1.73 m² with evidence of kidney damage for longer than 3 months, as defined by structural or functional abnormalities of the kidneys

  • Number: epoetin alfa (118), no treatment (39)

  • Mean age ± SD (years): epoetin alfa (84.1 ± 9.2), no treatment (84.4 ± 10.9)

  • Sex (M/F): epoetin alfa (28/90), no treatment (6/33)

  • Other characteristics: residents of long‐term care facility; Hb < 11.0 g/dL; adequate iron stores

  • Exclusion criteria: NS

Interventions Treatment group
  • Epoetin alfa

    • SC, 20,000 IU every 2 weeks to Hb level 10.0 to 12.0 g/dL for 6 months


Control group
  • No treatment (standard care)


Iron supplementation
  • Oral

Outcomes Primary trial outcome
  • "Safety and efficacy"


Outcomes extracted for meta‐analysis
  • All‐cause mortality

  • Transfusion

  • Major cardiovascular events

  • Myocardial infarction

  • Stroke

  • Hypertension

Notes
  • Funding: Centocor Ortho

  • Trials registration: NCT0337935

  • Contact with authors: contacted and additional data received

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
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not described
Incomplete outcome data (attrition bias) All outcomes High risk 27/118 lost to follow‐up in epoetin alfa arm (22.9%) and 10/39 lost to follow‐up in standard treatment arm (25.6%)
Selective reporting (reporting bias) Low risk Data for major cardiovascular events available
Other bias High risk Sponsor on authorship; change in protocol; medical writing assistance by sponsor