RUBRA Study 2008.

Methods	Study design: parallel group, open‐label RCT Time frame: NS Duration of study: 36 weeks; evaluation 29 to 36 weeks
Participants	Country: international Setting: multicentre Aged ≥ 18 years; HD or PD ≥ 12 weeks; stable on EPO ≥ 8 weeks; baseline Hb 10.5 to 13.0 g/dL; adequate iron stores, serum ferritin ≥100 ng/mL or TSAT ≥ 20% Number: treatment group 1 (104); treatment group 2 (168) Mean age ± SD (years): treatment group 1 (59.8 ± 14.4); treatment group 2 (60.1 ± 13.9) Sex (M/F): treatment group 1 (104/64); treatment group 2 (113/55) Exclusion criteria: blood transfusions < 8 weeks; GI bleeding; non‐renal causes of anaemia; CAD; liver disease; uncontrolled hypertension
Interventions	Treatment group 1 CERA: SC or IV every two weeks Initial dose based on EPO dose received during week preceding randomisation. Patients receiving weekly EPO > 8000, 8000 to 16,000 or > 16,000 IU were administered a starting CERA twice weekly dose of 60, 100 or 180 μg respectively Treatment group 2 EPO: continued, once/wk or 3 times/wk SC/IV Other information Dose adjustments were permitted for safety at any point during the study to maintain individual's Hb within 1g/dL of baseline value and within 10.0 to 13.5 g/dL. For CERA dose adjustment was not permitted more frequently than once every 4 weeks Co‐interventions Iron supplementation was performed according to individual centre practice
Outcomes	Final Hb Number reaching target Hb Median dose of ESA Adverse events
Notes	Information on sequence generation and allocation concealment requested from authors: no information received
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	NS
Allocation concealment (selection bias)	Unclear risk	Stratified by geographical region and route of administration
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; 54/282 (19%) withdrew due to AEs (4), death (16), transplantation (16), insufficient therapeutic response (1), refusal of treatment (1), failure to return (1), other (12)
Selective reporting (reporting bias)	High risk	All important outcomes provided. ITT data only available graphically and PP data entered in meta‐analyses
Other bias	High risk	Funded by Roche