A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients.

Phase 3 Completed 80 enrolled Hoffmann-La Roche

RandomizedParallel-groupOpen-labelTreatment

Summary

This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Timeline

Start: 2007-11
Primary completion: 2009-12
Completion: 2009-12

Outcome

Met primary endpoint

paper As the lower limit of 95% CI was higher than pre-specified 60% response rate, it can be concluded that CERA corrected anemia (P<0.05). PMID 24431909 ↗

Publications

Oh J, Joo KW, Chin HJ, Chae DW, Kim SG, Kim SJ, Chung W, Kim S, Huh W, Oh HY, Choi BS, Yang CW, Kim S. Correction of anemia with continuous erythropoietin receptor activator in Korean patients on long-term hemodialysis. J Korean Med Sci. 2014 Jan;29(1):76-83. doi: 10.3346/jkms.2014.29.1.76. Epub 2013 Dec 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	epoetin alfa	Protein / enzyme biologic	—	Intravenous
Subject	methoxy polyethylene glycol-epoetin beta	Protein / enzyme biologic	0.6 ug/kg	Intravenous