From previous studies, the frequency of administration of recombinant human erythropoietin injection (rHuEPO) has no association with its therapeutic effect in renal anemia in chronic kidney disease (CKD), and there is no significant difference in the efficacy between weekly single dosing and divided dosing. Most hemodialysis patients are clinically treated with moderate-dose rHuEPO, but there is a lack of research on the safety of single and divided administration of moderate-dose rHuEPO.

To compare the safety between weekly single and divided administration of moderate-dose rHuEPO for renal anemia in maintenance hemodialysis patients.

This study was designed as a randomized, parallel-group controlled, non-inferiority clinical trial. Eighty-eight patients with renal anemia who underwent maintenance hemodialysis at the Hemodialysis Room, Tongzhou Branch, Dongzhimen Hospital, Beijing University of Chinese Medicine from January 2019 to May 2021 were selected and randomly divided into an experimental group and a control group with 44 in each. For comparing the safety and efficacy of weekly single and divided administration of moderate-dose rHuEPO, 29 cases (experimental subgroup 1) and other 15 cases (experimental subgroup 2) in the experimental group received an rHuEPO dose of 6 000 U, and an rHuEPO dose of 4 000 U, once a week, respectively; 30 cases (control subgroup 1) in the control group received a single rHuEPO dose of 2 000 U, three times a week (6 000 U per week in total), and other 14 cases (control subgroup 2) received a single rHuEPO dose of 2 000 U, twice a week (4 000 U per week in total) .

Safety analysis: two-factor repeated-measures ANOVA showed that the type of intervention scheme and duration had no interaction effects on systolic blood pressure, diastolic blood pressure, mean arterial pressure, and pre-dialysis serum potassium between experimental subgroup 1 and control subgroup 1, and between experimental subgroup 2 and control subgroup 2 (P>0.05), and produced no main effects on systolic blood pressure, diastolic blood pressure, mean arterial pressure, and pre-dialysis serum potassium in experimental subgroup 1 and control subgroup 1, and between experimental subgroup 2 and control subgroup 2 (P>0.05). The serum levels of AST, ALT and TBiL were similar between experimental subgroup 1 and control subgroup 1 at baseline and 12 weeks of treatment (P>0.05). Likewise, they were similar between experimental subgroup 2 and control subgroup 2 at baseline and 12 weeks of treatment (P>0.05). No thromboembolic, cardiovascular or cerebrovascular events and gastrointestinal reactions related to rHuEPO occurred in any of the subgroups during the 12-week treatment. Efficacy analysis: the hemoglobin level (reference range was 110-130 g/L) in experimental subgroup 1 〔65.5% (19/29) 〕was similar to that in control subgroup 1 〔73.3% (22/30) 〕at 12 weeks of treatment (χ^2=0.425, P=0.514). The serum levels of hemoglobin were similar between experimental subgroup 2 and control subgroup 2 at 12 weeks of treatment (P>0.05). The levels of red blood cell count, hematocrit, percentage and absolute number of reticulocytes, ferritin and transferrin saturation did not vary between experimental subgroup 1 and control subgroup 1, and between experimental subgroup 2 and control subgroup 2 either at baseline or 12 weeks of treatment (P>0.05) .

Weekly single and divided administration of moderate-dose erythropoietin had no significant difference in medication safety in the treatment of renal anemia in maintenance hemodialysis patients.