STRIATA Study 2008.

Methods	Study design: open‐label, parallel RCT Study duration: NS Duration of follow‐up: 52 weeks
Participants	Countries: Europe (12 countries), Australia, Canada Setting: multicentre (48 centres) Aged ≥18 years; chronic anaemia receiving HD; Kt/V ≥ 1.2 or urea reduction ≥ 65%; PD weekly Kt/V ≥ 1.8 for ≥ 12 weeks; IV DA therapy weekly or 2 weekly ≥ 8 weeks Number (randomised/evaluated): treatment group 1 (157/123); treatment group 2 (156/126) Mean age ± SD (years): treatment group 1 (62.49 ± 16.17); treatment group 2 (61.8 ± 14.74) Sex (M/F): treatment group 1 (100/57); treatment group 2 (81/75) Exclusion criteria: non‐renal causes of anaemia; CRP > 30 mg/L; life expectancy < 12 months
Interventions	Treatment group 1 CERA: IV 2 weekly Starting CERA dose calculated according to DA dose before randomisation. 60 μg to 180 μg/2 weeks Treatment group 2 DA: IV weekly or 2 weekly according to previous dose During dose titration and evaluation, doses in both groups were adjusted to maintain Hb within 1.0 g/dL of baseline or Hb values between 10 and 13.5 g/dL Other information Dose adjustments for CERA were performed not more frequently than once every 4 weeks Co‐interventions IV iron supplements as required in both treatment groups
Outcomes	Mean Hb change between baseline and evaluation (29 to 36 weeks) Proportion patients maintaining Hb ± 1 g/dL of baseline during evaluation. Incidence of RBC transfusions Adverse effects
Notes	Request for ITT data (only available graphically in report) made to authors: no information obtained
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomization numbers "allocated sequentially for each study centre"
Allocation concealment (selection bias)	Low risk	"Central randomization centre"
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 for. Loss to follow‐up/withdrawals: death (22), transplantation (20), refusal of treatment (7), adverse events (2), failure to return (2), patient vacation, patient decision, patient instability, protocol violation, discontinuation of dialysis (11)
Selective reporting (reporting bias)	High risk	ITT data only provided graphically and PP data entered in meta‐analyses
Other bias	High risk	Funded by F.Hoffman‐ La Roche Ltd. Basel Switzerland; data analyses conducted by sponsor