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Clinical Trial
. 2014 Jan;29(1):76-83.
doi: 10.3346/jkms.2014.29.1.76. Epub 2013 Dec 26.

Correction of anemia with continuous erythropoietin receptor activator in Korean patients on long-term hemodialysis

Jieun Oh  1 , Kwon-Wook Joo  2 , Ho-Jun Chin  3 , Dong-Wan Chae  3 , Sung-Gyun Kim  1 , Soo Jin Kim  1 , Wookyung Chung  4 , Sejoong Kim  3 , Wooseong Huh  5 , Ha Young Oh  5 , Bum Soon Choi  6 , Chul-Woo Yang  6 , Suhnggwon Kim  2
Affiliations
Clinical Trial

Correction of anemia with continuous erythropoietin receptor activator in Korean patients on long-term hemodialysis

Jieun Oh et al. J Korean Med Sci. 2014 Jan.

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 (≥ 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 ≥ 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).

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

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Conflict of interest statement

The authors have no conflicts of interest to disclose. The sponsor of this study, Roche, Korea Co., Ltd. designed the study and provided statistical analysis of the data.

Figures

Fig. 1
Fig. 1
Study design. Sc, screening; wk, week; CERA, Continuous erythropoietin receptor activator.
Fig. 2
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.
Fig. 3
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.
Fig. 4
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.
Fig. 5
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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