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Clinical Trial Details

Trial ID: L0815
Source ID: NCT05211167
Associated Drug: Human Erythropoiesis Injection (Cho Cell)
Title: Phase III Clinical Study of Recombinant Erythropoiesis Stimulating Protein Injection (rESP) in the Treatment of Anemia in Hemodialysis Patients With Chronic Renal Failure
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Kidney Failure, Chronic|Hemodialysis
Interventions: DRUG: Human Erythropoiesis Injection (CHO cell)|DRUG: Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)
Outcome Measures: Primary: hemoglobin concentration, the amount of change in mean Hb concentration compared with baseline Hb concentration during the evaluation period, 25th-32nd week | Secondary: maintenance rate, the proportion of subjects whose average Hb concentration remained within the target range during the evaluation period, 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), for 32 weeks|proportion of times, the proportion of times the measured Hb concentration remains within the target range during the subject evaluation period, 25th-32nd week|average weekly dose, the average weekly dose of the drug during the evaluation period, 25th-32nd week|average hemoglobin concentration, the mean Hb concentration during the evaluation period, 25th-32nd week|mean reticulocyte count, changes in mean values of reticulocyte compared to baseline values during the evaluation period, 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, 25th-32nd week|adverse events, the type, proportion and severity of adverse events, for 32 weeks|number of dose adjustments, the number of dose adjustments used by the subject during the treatment and evaluation period, for 32 weeks|the ratio of subjects who are adjusted, the ratio of subjects who are adjusted during the treatment and evaluation period, for 32 weeks|incidence of Human Erythropoietin antibodies and anti-rESP antibodies, incidence of Human Erythropoietin antibodies and anti-rESP antibodies, for 32 weeks|Maximum Plasma Concentration (Cmax), the Cmax of rESP in patients with long-term medication, for 32 weeks|Area Under the Curve (AUC), the AUC of rESP in patients with long-term medication, for 32 weeks
Sponsor/Collaborators: Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 300
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-07-01
Completion Date: 2023-12-30
Results First Posted:
Last Update Posted: 2022-01-27
Locations: Chinese PLA General Hospital, Beijing, Beijing, 200443, China
URL: https://clinicaltrials.gov/show/NCT05211167