Prospective Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Nephrol. Nov 25, 2021; 10(6): 109-121
Published online Nov 25, 2021. doi: 10.5527/wjn.v10.i6.109
Efficacy and safety of recombinant human erythropoietin (Hema-Plus®) for management of anemia in Thai patients on peritoneal dialysis
Piyatida Chuengsaman, Surapong Narenpitak, Suchai Sritippayawan
Piyatida Chuengsaman, Banphaeo Dialysis Group, Banphaeo Hospital (Public Organization), Banphaeo 74120, Samutsakhon, Thailand
Surapong Narenpitak, Department of Medicine, Udon Thani Hospital, Udon Thani 41000, Thailand
Suchai Sritippayawan, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
Author contributions: All authors contributed in design and oversight of the study, and were involved with data collection at their sites, reviewed the results from statistical analysis and interpretation of the statistic results, read and approved the final manuscript; Chuengsaman P mainly drafted the manuscript.
Institutional review board statement: The study was reviewed and approved by the Ethics Committee, Institute for the Development of Human Research Protections (IHRP), No. IHRP 2365/2556; The Ethics Committee of Udon Thani Hospital, No. 8/2559; and Siriraj Institutional Review Board Faculty of Medicine Siriraj Hospital, Mahidol University, No. Si 588/2016.
Clinical trial registration statement: The study was registered on the Thai Clinical Trial Registry (TCTR), (TCTR ID: 20140128002).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
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.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: We did not use CONSORT (for reporting a randomised trial).
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Corresponding author: Piyatida Chuengsaman, MD, Doctor, Banphaeo Dialysis Group, Banphaeo Hospital (Public Organization), 198 Moo 1 Banphaeo, Banphaeo 74120, Samutsakhon, Thailand.
Received: May 9, 2021
Peer-review started: May 9, 2021
First decision: June 6, 2021
Revised: August 19, 2021
Accepted: September 15, 2021
Article in press: September 15, 2021
Published online: November 25, 2021
Research background

The Hema-Plus is a locally made recombinant human erythropoietin (rHuEPO) that may help Thai people to gain more accessibility to epoetin alfa in Thailand due to lower costs.

Research motivation

There are no publicly available studies of Hema-Plus in Thai chronic kidney disease (CKD) patients on peritoneal dialysis (PD). The results from this study may be used as an evidence and information for considering to use Hema-Plus, locally made rHuEPO in these patients.

Research objectives

This study aimed to evaluate the efficacy and safety of Hema-Plus for treatment of anemia during correction phase in Thai patients with Stage V CKD on PD.

Research methods

An open-label, multi-center study of Hema-Plus in patients was used to assess the efficacy, i.e., mean change in hemoglobin (Hb) level from baseline, safety, and changes in quality of life (QoL) after receiving the study drug for 12 wk.

Research results

Efficacy analysis comprised 30 patients. At the end of 12 wk-treatment, mean Hb was statistically significantly increased from baseline. Two hypertensive urgency events were observed probably related to study medication. QoL scores were significantly increased from baseline.

Research conclusions

Hema-Plus administered for 12 wk for treatment of anemia in CKD patients on PD effectively could increase Hb levels, and QoL with acceptable safety profile.

Research perspectives

This study results could be used as an evidence for efficacy and safety information of the locally made rHuEPO, Hema-Plus for anemia correction phase. Longer study duration is suggested to ensure long-term safety and efficacy.