J Korean Med Sci.  2014 Jan;29(1):76-83. 10.3346/jkms.2014.29.1.76.

Correction of Anemia with Continuous Erythropoietin Receptor Activator in Korean Patients on Long-Term Hemodialysis

• 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

• KMID: 1796918
• DOI: http://doi.org/10.3346/jkms.2014.29.1.76

Abstract

Continuous erythropoietin receptor activator (CERA) is an erythropoietin with a long-half life. This study investigated the efficacy of CERA for correcting anemia in Korean patients on dialysis. Patients (> or =18 yr) who were not receiving any ESAs for more than 8 weeks were randomly assigned to either intravenous CERA once every 2 weeks (n=39) or epoetin beta thrice-weekly (n=41) during a 24-week correction phase. Hemoglobin (Hb) response was defined as increase of Hb by at least 1 g/dL and Hb> or =11 g/dL without red blood cell (RBC) transfusion. Median dialysis duration was 1.7 (0.3-20.8) and 1.6 (0.4-13.8) yr in CERA and epoetin beta group, respectively. Hemoglobin response rate of CERA was 79.5% (95% confidence interval [CI], 63.5-90.7). 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). Hb response rate of epoetin beta was 87.8% (95% CI, 73.8-95.9) (P=0.37). Median time to response was 12 weeks in CERA and 10.3 weeks in epoetin beta (P=0.03). It is suggested that once every 2 weeks administration of CERA is effective for correcting anemia in Korean patients on long-term hemodialysis with longer time-to-response than thrice weekly epoetin beta. (ClinicalTrials.gov registry No. NCT00546481)

Keyword

Anemia Correction; Continuous Erythropoietin Receptor Activator; Kidney Failure, Chronic; Renal Dialysis

MeSH Terms

Anemia/*drug therapy
Erythropoietin/*therapeutic use
Female
Hemoglobins/analysis
Humans
Male
Middle Aged
Polyethylene Glycols/*therapeutic use
Quality of Life
Recombinant Proteins/therapeutic use
Renal Dialysis
Renal Insufficiency, Chronic/*drug therapy
Republic of Korea
Hemoglobins
Polyethylene Glycols
Recombinant Proteins
Erythropoietin

Figure

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  Fig. 1 Study design. Sc, screening; wk, week; CERA, Continuous erythropoietin receptor activator.

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  Fig. 2 Enrollment, randomization, and study completion. *RBC transfusion; §One patient from each group had sufficient Hb measurements (> 75%) during correction phase and was included in per protocol analysis.

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  Fig. 3 Mean hemoglobin levels. (A) Changes over time from baseline (BL) during the correction phase in CERA IV once every 2 weeks and epoetin beta IV three times per week group (ITT set) (P = 0.18, repeated measures ANOVA). (B) Changes during the maintenance phase. Values are mean ± SD. CERA, Continuous erythropoietin receptor activator.

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  Fig. 4 Changes in quality of life evaluated by using SF-36 Health Survey. A clinically meaningful change is defined as a change greater than 5 points from baseline. (A) At week 13. (B) At week 25. CERA, Continuous erythropoietin receptor activator.

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  Fig. 5 Change of iron parameters during the correction phase. Values are median with interquartile range. (A) Transferrin saturation (TSAT) (P = 0.38, repeated measures ANOVA). (B) Ferritin (P = 0.94, repeated measures ANOVA). CERA, Continuous erythropoietin receptor activator.

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