EMERALD 2 Study 2013.

Methods	Study design: open‐label, parallel RCT Start date: October 2007
Participants	Inclusion criteria Participants with CKD on HD for ≥ 3 months prior to randomisation On IV epoetin alfa or beta maintenance therapy continuously prescribed for a minimum of 8 weeks prior to randomisation Four consecutive Hb values with a mean ≥ 10.0 and ≤ 12.0 g/dL during the screening period Exclusion criteria Females who are pregnant or breast‐feeding Known intolerance to any ESA or pegylated molecule or to all parenteral iron supplementation products Known bleeding or coagulation disorder Known hematologic disease or cause of anaemia other than kidney disease Poorly controlled hypertension. Evidence of active malignancy within one year prior to randomisation Temporary (untunneled) dialysis access catheter A scheduled kidney transplant A scheduled surgery that may be expected to lead to significant blood loss
Interventions	Peginesatide IV or SC injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the screening period; the first dose was administered one week after the last epoetin alfa or beta dose. The dose was adjusted to maintain haemoglobin levels in a target range of 10.0 to 12.0 g/dL and ± 1.5 g/dL from baseline during the titration and evaluation periods, and 10.0 to 12.0 g/dL during the long‐term safety and efficacy period Epoetin alfa or beta Continued to receive commercially available epoetin alfa by IV or SC injection, at the same starting dose and frequency as received during the last week of the screening period, with the first study dose of epoetin alfa administered after randomisation at Week 0. The dose was adjusted to maintain haemoglobin levels in a target range of 10.0 to 12.0 g/dL and ± 1.5 g/dL from baseline during the titration and evaluation periods, and 10.0 to 12.0 g/dL during the long‐term safety and efficacy period
Outcomes	Mean change in Hb between baseline and the evaluation period (baseline and weeks 29 to 36) Proportion of participants who receive RBC transfusions during the titration and evaluation periods Proportion of participants whose mean Hb level during the evaluation period is within the target range of 10.0 to 12.0 g/dL
Notes

CKD ‐ chronic kidney disease; ESA ‐ erythropoiesis stimulating agent; Hb ‐ haemoglobin; HD ‐ haemodialysis; IV ‐ intravenous; RBC ‐ red blood cell; RCT ‐ randomised controlled trial; SC ‐ subcutaneous