NCT00717821.

Trial name or title	A randomized, controlled, open label, french multicenter parallel group study to compare the hemoglobin maintenance with once monthly administration of mircera versus epoetin beta or darbepoetin alfa in patients with chronic kidney disease on hemodialysis
Methods	Open‐label, parallel RCT
Participants	Inclusion criteria Adult patients,≥18 years regular long term HD with same schedule for ≥ 12 weeks continuous IV or SC maintenance epoetin beta or darbepoetin alfa therapy, with the same dosing interval during the previous month, and no change in total weekly dose Exclusion criteria transfusion of red blood cells during previous 2 months significant acute or chronic bleeding poorly controlled hypertension requiring hospitalisation or interruption of epoetin beta/darbepoetin alfa treatment in previous 6 months weekly dose of epoetin beta >16000 UI, or weekly dose of darbepoetin alfa >80 µg during previous month
Interventions	Treatment group 1 Methoxy polyethylene glycol‐epoetin beta (Mircera): 120 µg or 200 µg IV or SC (starting dose) Treatment group 2 Epoetin beta or darbepoetin alfa: as prescribed
Outcomes	Primary outcome measures Percentage of patients maintaining average Hb concentration within target range (10 to 12 g/dL) during evaluation period Secondary outcome measures Mean change in Hb concentration between reference and evaluation period, and mean time spent in Hb range of 10 to 12g/dL during evaluation period Dose adjustments, RBC transfusions, adverse events
Starting date	October 2008
Contact information	Hoffmann‐La Roche
Notes

CKD ‐ chronic kidney disease; ESA ‐ erythropoiesis stimulating agent; GI ‐ gastrointestinal; IV ‐ intravenous; RCT ‐ randomised controlled trial; SC ‐ subcutaneous; TSAT ‐ transferrin saturation