To verify the efficacy of recombinant erythropoiesis stimulating protein injection (CHO cell) in hemodialysis patients with chronic renal failure anemia maintenance treatment is not inferior to yibio.
In this phase 3, open label, active comparator parallel controlled study, patients were randomly assigned to two study groups: one active comparator control group (Human Erythropoietin Injection , maintaining the same dose and frequency administrated in the sceening period ), and experimental groups (50μg, once every two weeks). All the patients were administered intravenously for 32 weeks and were evaluated the efficacy, safety and pharmacokinetic characteristics. During the whole study period, dosage adjustment was not allowed in the first 4 weeks, while in the remaining trial period dosage adjustment was allowed once every two weeks if necessary.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Human Erythropoiesis Injection (CHO cell) is a recombinant human erythropoietin with the same biological effects as natural erythropoietin
rESP is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGhemoglobin concentration
the amount of change in mean Hb concentration compared with baseline Hb concentration during the evaluation period
Time frame: 25th-32nd week
maintenance rate
the proportion of subjects whose average Hb concentration remained within the target range during the evaluation period
Time frame: 25th-32nd week
proportion of subjects
the proportion of subjects whose range of dose adjustments decreased or increased by 25% still did not reach 100-120 g/L (both ends)
Time frame: for 32 weeks
proportion of times
the proportion of times the measured Hb concentration remains within the target range during the subject evaluation period
Time frame: 25th-32nd week
average weekly dose
the average weekly dose of the drug during the evaluation period
Time frame: 25th-32nd week
average hemoglobin concentration
the mean Hb concentration during the evaluation period
Time frame: 25th-32nd week
mean reticulocyte count
changes in mean values of reticulocyte compared to baseline values during the evaluation period
Time frame: 25th-32nd week
mean red blood cell count
changes in mean values of red blood cell count compared to baseline values during the evaluation period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 25th-32nd week
adverse events
the type, proportion and severity of adverse events
Time frame: for 32 weeks
number of dose adjustments
the number of dose adjustments used by the subject during the treatment and evaluation period
Time frame: for 32 weeks
the ratio of subjects who are adjusted
the ratio of subjects who are adjusted during the treatment and evaluation period
Time frame: for 32 weeks
incidence of Human Erythropoietin antibodies and anti-rESP antibodies
incidence of Human Erythropoietin antibodies and anti-rESP antibodies
Time frame: for 32 weeks
Maximum Plasma Concentration (Cmax)
the Cmax of rESP in patients with long-term medication
Time frame: for 32 weeks
Area Under the Curve (AUC)
the AUC of rESP in patients with long-term medication
Time frame: for 32 weeks