PMID- 34909408
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20211217
IS  - 2220-6124 (Print)
IS  - 2220-6124 (Electronic)
IS  - 2220-6124 (Linking)
VI  - 10
IP  - 6
DP  - 2021 Nov 25
TI  - Efficacy and safety of recombinant human erythropoietin (Hema-Plus((R))) for 
      management of anemia in Thai patients on peritoneal dialysis.
PG  - 109-121
LID - 10.5527/wjn.v10.i6.109 [doi]
AB  - BACKGROUND: Hema-Plus, a recombinant human erythropoietin (rHuEPO) or epoetin 
      alfa has shown effectiveness in correction of anemia in Thai population in 
      clinical practice. This study was aimed to demonstrate efficacy and safety under 
      the evidence-based approach. AIM: To evaluate the efficacy and safety of rHuEPO 
      (Hema-Plus) for treatment of anemia over 12 wk in Thai patients with Stage V 
      chronic kidney disease (CKD) on peritoneal dialysis (PD). METHODS: This study was 
      an open-label, multi-center study to enroll 30 CKD patients identified to start 
      PD with hemoglobin (Hb) less than 9.5 g/dL, serum ferritin more than 100 ng/mL, 
      serum transferrin saturation more than or equal to 20% and who had not previously 
      received epoetin. Patients with conditions that could increase the risk of 
      adverse effects from study participation or interfere with study outcomes, were 
      using concomitant androgens or had secondary hyperparathyroidism were excluded. 
      All eligible patients started Hema-Plus by SC injection at 4000 IU once or twice 
      weekly (week 0) and with follow-up at weeks 2, 4, 8, and 12. Dosage adjustment 
      could be done to achieve Hb level of 11-12 g/dL. Primary end point was mean 
      change in Hb level from baseline to end of treatment (week 12). Safety was 
      assessed throughout the study. Quality of life (QoL) was assessed using KDQOL-36. 
      RESULTS: All 30 enrolled patients completed the study. Mean (standard deviation) 
      Hb at baseline (week 0) to the end of 12 wk was significantly increased from 7.39 
      (1.29) g/dL to 11.15 (1.73) g/dL (paired t-test, P value < 0.001). Overall change 
      of Hb means from baseline over the other 4 visits was statistically significantly 
      increased (repeated measure ANOVA, P value < 0.001). Ten out of 39 adverse events 
      (AEs) were serious. Two serious AEs were probably related to study medication by 
      investigators' assessment. At week 12, the QoL scores in all domains were 
      significantly increased from baseline. CONCLUSION: Hema-Plus administered for 12 
      wk for treatment of anemia in patients on PD effectively increased Hb levels with 
      acceptable safety profile.
CI  - (c)The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights 
      reserved.
FAU - Chuengsaman, Piyatida
AU  - Chuengsaman P
AD  - Banphaeo Dialysis Group, Banphaeo Hospital (Public Organization), Banphaeo 74120, 
      Samutsakhon, Thailand. pchuengsaman@gmail.com.
FAU - Narenpitak, Surapong
AU  - Narenpitak S
AD  - Department of Medicine, Udon Thani Hospital, Udon Thani 41000, Thailand.
FAU - Sritippayawan, Suchai
AU  - Sritippayawan S
AD  - Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol 
      University, Bangkok 10700, Thailand.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - World J Nephrol
JT  - World journal of nephrology
JID - 101610229
PMC - PMC8641037
OTO - NOTNLM
OT  - Anemia
OT  - Chronic kidney disease
OT  - Epoetin alfa
OT  - Peritoneal dialysis
OT  - Recombinant human erythropoietin
COIS- Conflict-of-interest statement: All authors declare no potential conflicting 
      interests related to this paper. Although, Apexcela Co., Ltd. supported for the 
      study funding and medication, the study was conducted and the study results were 
      interpreted without the influence of the pharmaceutical company.
EDAT- 2021/12/16 06:00
MHDA- 2021/12/16 06:01
PMCR- 2021/11/25
CRDT- 2021/12/15 12:31
PHST- 2021/05/09 00:00 [received]
PHST- 2021/08/19 00:00 [revised]
PHST- 2021/09/15 00:00 [accepted]
PHST- 2021/12/15 12:31 [entrez]
PHST- 2021/12/16 06:00 [pubmed]
PHST- 2021/12/16 06:01 [medline]
PHST- 2021/11/25 00:00 [pmc-release]
AID - 10.5527/wjn.v10.i6.109 [doi]
PST - ppublish
SO  - World J Nephrol. 2021 Nov 25;10(6):109-121. doi: 10.5527/wjn.v10.i6.109.