Locatelli 2004.

Methods	Study design: parallel RCT Study duration/time frame: 25 August 2002 to 29 September 2003 Duration of follow‐up: 30 weeks
Participants	Countries: UK, Europe Setting: multicentre Age: ≥ 18 years; HD ≥ 6 months; on stable IV rHuEPO 1 to 3 times/wk; baseline Hb 10.0 to 13.0 g/dL Number: treatment group 1 (154); treatment group 2 (154) Mean age ± SD (years): NS Sex (M/F): NS Exclusion criteria: seizures ≤ 6 months; CHF; uncontrolled hypertension; current malignancy; surgery within 3 months; systemic haematological disease; RBC transfusion 12 weeks before screening
Interventions	Treatment group 1 DA: IV every two weeks for 30 weeks Starting dose was previous weekly EPO dose in units divided by 200 multiplied by 2 Treatment group 2 DA: IV every week for 30 weeks Starting dose was previous weekly EPO dose in units divided by 200. Other information Dose was titrated for each patient throughout the study to maintain Hb within ‐1.0 to + 1.5 g/dL of baseline and between 10.0 and 13.0 g/dL Co‐interventions NS
Outcomes	Final Hb Instability of Hb concentrations DA alfa dosing requirements RBC transfusions Adverse events
Notes	Multiple abstracts Additional information from www.amgentrials.com Data sought from authors: randomisation process
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Sequence generation not stated. Stratified by centre according to EPO dose "randomly assigned"
Allocation concealment (selection bias)	Unclear risk	Randomisation stated but no information on method used available
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Blinding maintained by placebo injections weekly in patients on 2 weekly regimen. Unclear whether both participants and personnel blinded. Primary outcome is laboratory measurement
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinding maintained by placebo injections weekly in patients on 2 weekly regimen
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear. Abstracts only; 213/307 (69%) were included in primary analysis; deaths (19), adverse events (5)
Selective reporting (reporting bias)	High risk	Important outcomes provided but data for primary outcome only provided for PP population
Other bias	High risk	Funding Amgen Inc, Thousand Oaks, CA