A phase 2, randomized, open label, active comparator parallel controlled study to explore the dosage regiment of rESP, and evaluate its efficacy, safety and pharmacokinetic characteristics in the treatment of anemia in chronic renal failure patients with hemodialysis
In this phase 2, open label, active comparator parallel controlled study, patients were randomly assigned to three study groups: one active comparator control group (rHu EPO, maintaining the same dose and frequency administrated in the sceening period ), and two experimental groups (0.5μg/kg ,once a week; 1.0μg/kg , 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
150
rHuEPO 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
The general hospital of the people's liberation army
Beijing, Beijing Municipality, China
RECRUITINGPrimary efficacy index :hemoglobin concentration
the amount of change in mean Hb concentration compared with baseline Hb concentration during the evaluation period (25th-32nd week)
Time frame: 25th-32nd week
Secondary efficacy index:maintenance rate
the proportion of subjects whose average Hb concentration remained within the target range during the evaluation period
Time frame: 25th-32nd week
Secondary efficacy index :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
Secondary efficacy index: 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
Secondary efficacy index : average weekly dose
the average weekly dose of the drug during the evaluation period (normalized by body weight)
Time frame: 25th-32nd week
Secondary efficacy index: EPO dose conversion coefficient of rESP
the EPO dose conversion coefficient of rESP (the average weekly dose of rESP during the screening period) and the dose correlation
Time frame: for 32 weeks
Secondary efficacy index : mean reticulocyte count
changes in mean values of reticulocyte compared to baseline values during the evaluation period.
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Time frame: 25th-32nd week
Secondary efficacy index : mean red blood cell count
changes in mean values of red blood cell count compared to baseline values during the evaluation period
Time frame: 25th-32nd week
Safety indicator: adverse events
the type, proportion and severity of adverse events
Time frame: for 32 weeks
Safety indicator: number of dose adjustments
the number of dose adjustments used by the subject during the treatment and evaluation period
Time frame: for 32 weeks
Safety indicator: 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
Safety indicator: incidence of erythropoietin (EPO) antibodies and anti-rESP antibodies
incidence of erythropoietin (EPO) 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