The purpose of the study is to explore the optimal dose and administration of the experimental drug, and to evaluate the safety and efficacy of the drug in patients with renal anemia. Patients with renal anemia on regular dialysis treatment are expected to be enrolled in this study.
This study is a multi-center, randomized, open-label, positive controlled phase II clinical study. A total of 125 to 150 patients with renal anemia receiving regular dialysis were enrolled in this study. Those patients were randomly allocated to 5 treatment groups in a ratio of 1:1:1:1:1, with 25 to 30 patients in each group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
The dose of PEG-EPO (CHO cells) is converted according to the average weekly dose of short-acting EPO before randomization (4 weeks before randomization) multiplied by the corresponding conversion coefficient (low conversion coefficient is 0.004, High conversion coefficient is 0.008).
Refer to the product instructions
The First Affiliated Hospitial,College of Medicine,Zhejiang University
Hanzhou, Zhejiang, China
RECRUITINGChange of mean hemoglobin compared to baseline during fixed treatment
Change of mean hemoglobin (Hb) content from baseline during fixed treatment (fixed treatment:week 1 to week 6)
Time frame: Day1-Day42
Change of mean hemoglobin during dose adjustment period
Change of mean hemoglobin compared to baseline from week 13 to 18 during dose adjustment period (dose adjustment period: week 7 to week 18/week 20).
Time frame: Day85-Day126
Proportion of patients with hemoglobin keeping within the target range
Proportion of patients with hemoglobin keeping within the target range (target range: the variation from baseline Hb is within ±10g/L, and HB is in the range of 100-130g/L) during treatment period (fixed treatment, week 13 to 18 during dose adjustment period).
Time frame: Day1-Day42、Day85-Day126
Reticulocyte count, Hematocrit, Erythrocyte count
Changes of mean values of other evaluation indexes (including HCT, RET, RBC) between baseline and different stages of treatment (fixed treatment period, week 13 to 18 of dose adjustment period).
Time frame: Day1-Day42、Day85-Day126
Proportion of patients receiving red blood cell transfusion and number of transfusions during the trial.
Time frame: Day1-Day126/140
Number of iron deficiency, number of patients and proportion of patients with iron deficiency during the trial
Iron deficiency was defined as SF≤100μg/L and TSAT≤20% in peritoneal dialysis subjects; SF≤200μg/L and TSAT≤20% in hemodialysis subjects.
Time frame: Day1-Day126/140
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The number and proportion of patients with dose adjustments during the trial
Time frame: Day1-Day126/140
Anti-drug antibody
The incidence of ADA and Nab
Time frame: 1,5, 9, 13, 17 weeks (before administration) and 28±2 days after the last administration (A2/B2group ,A1/B1 patients with intensive blood collection) or 14±2 days after the last administration (A1/B1 patients with sparse blood collection)
Adverse events
Any adverse event that occurred during the clinical trials of all patients.
Time frame: Day1-Day126/140
Cmax
Maximum observed plasma concentration of EPO.
Time frame: Day1-Day126/140
Tmax
Time to maximum observed plasma concentration of EPO.
Time frame: Day1-Day126/140
AUC 0-t
Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration of EPO.
Time frame: Day1-Day126/140
AUC 0-∞
Area under the plasma concentration-time curve from time 0 to infinity.
Time frame: Day1-Day126/140
Emax
Maximal effect concentriation
Time frame: Day1-Day126/140
Tmax of Emax
Time to maximal effect concentriation
Time frame: Day1-Day126/140
AUE0-t
Area under the plasma effect-concentriation curve from time 0 to the time of the last measurable concentration of EPO.
Time frame: Day1-Day126/140