Published online Nov 25, 2021. doi: 10.5527/wjn.v10.i6.109
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
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.
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.
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.
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.
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.
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.
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.