Vanrenterghem 2002.

Methods	Study design: parallel RCT Study duration: November 1997 to July 1998 Duration of follow‐up: 52 weeks
Participants	Countries: Europe, Australia Setting: multicentre HD/PD; age ≥18 years; stable rHuEPO for 3 months; stable Hb 9.5 to 12.5 g/dL; adequate iron stores serum ferritin > 100 μg/L Number (randomised/evaluated): treatment group 1 (347/224); treatment group 2 (175/112) Mean age, range (years): treatment group 1 (60.1,18 to 88); treatment group 2 (60.9, 22 to 87) Sex (M/F): treatment group 1 (188/159); treatment group 2 (100/75) Exclusion criteria: haematological, inflammatory or infectious conditions; blood transfusion < 1 month before enrolment
Interventions	Treatment group 1 DA: patients on rHuEPO once/wk converted to DA once every 2 weeks for 52 weeks Patients on EPO 2 to 3 times/wk converted to DA once/wk for 52 weeks Dose adjusted to maintain individual's Hb within ‐1.0 to + 1.5 g/dL of baseline and between 9 and 13 g/dL Treatment group 2 EPO: IV/SC once, twice or 3 times/wk for 52 weeks Dose adjusted to maintain Hb within ‐1.0 to + 1.5 g/dL of baseline, and 9 to 13 g/dL Evaluation at weeks 25 to 32 Co‐interventions IV iron therapy as required
Outcomes	Change in Hb ESA dosage Mortality Adverse events
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	NS
Allocation concealment (selection bias)	Low risk	Central randomisation. Stratified by centre and EPO dose at study entry
Blinding of participants and personnel (performance bias) All outcomes	Low risk	No blinding but outcome of Hb unlikely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) All outcomes	Low risk	No blinding but outcome of Hb unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) All outcomes	Low risk	All patients accounted; loss to follow‐up/withdrawals: 133 did not complete 52 weeks of study. Main reason was death (52), transplant and withdrawal requested; rates were similar between groups during evaluation period
Selective reporting (reporting bias)	High risk	Results provided for per protocol population with all results only provided graphically
Other bias	High risk	Amgen Inc funded study