Goh 2007

Methods	Study design: RCT Study duration: NS
Participants	Setting: 26 centres Country: Malaysia Stage of CKD: HD Mean age ± SD (years): epoetin alfa (49 ± 13), biosimilar epoetin alfa (49 ± 12) Sex (M/F): epoetin alfa (61/32), biosimilar epoetin alfa (45/48) Other characteristics: Hb ≥ 9 g/dL; adequate iron stores Exclusion criteria: pregnant or nursing woman; poorly controlled hypertension (DBP > 110 mm Hg); history of seizure disorder; active infection or inflammation; any illness that had required hospitalisation within previous month; recent blood transfusion; haematologic abnormalities (haemolysis, microcytosis, thrombocytosis); severe hyperparathyroidism; malignancy; history of mental illness; drug or alcohol abuse and known hypersensitivity to mammalian cell‐derived product or human albumin
Interventions	Treatment group Epoetin alfa IV aiming for Hb level > 8 g/dL Control group Biosimilar epoetin alfa IV aiming for Hb level > 8 g/dL Iron supplementation IV or oral as required
Outcomes	Primary trial outcome Change in Hb from baseline to week 12 Outcomes extracted for meta‐analysis All‐cause mortality Major cardiovascular events Transfusions Fatigue Breathlessness
Notes	Funding: NCPC GeneTech Biotechnology Company Trials registration: NCT00229099 Contact with study authors: not contacted
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Low risk	Randomised centrally
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not double‐dummy controlled
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Unclear
Incomplete outcome data (attrition bias) All outcomes	High risk	Discrepancy in proportion of patients lost in biosimilar ESA arm
Selective reporting (reporting bias)	Low risk	All patient‐relevant outcomes reported
Other bias	Low risk	None apparent