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Clinical Trial Details

Trial ID: L0316
Source ID: NCT03950687
Associated Drug: Recombinant Human Erythropoiesis Injection (Cho Cell)
Title: Study of rESP Injection for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Chronic Renal Failure With Hemodialysis
Interventions: DRUG: Recombinant Human Erythropoiesis Injection (CHO cell)|DRUG: Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)
Outcome Measures: Primary: Primary efficacy index :hemoglobin concentration, the amount of change in mean Hb concentration compared with baseline Hb concentration during the evaluation period (25th-32nd week), 25th-32nd week | Secondary: Secondary efficacy index:maintenance rate, the proportion of subjects whose average Hb concentration remained within the target range during the evaluation period, 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), 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, 25th-32nd week|Secondary efficacy index : average weekly dose, the average weekly dose of the drug during the evaluation period (normalized by body weight), 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, for 32 weeks|Secondary efficacy index : mean reticulocyte count, changes in mean values of reticulocyte compared to baseline values during the evaluation period., 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, 25th-32nd week|Safety indicator: adverse events, the type, proportion and severity of adverse events, for 32 weeks|Safety indicator: number of dose adjustments, the number of dose adjustments used by the subject during the treatment and evaluation period, 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, for 32 weeks|Safety indicator: incidence of erythropoietin (EPO) antibodies and anti-rESP antibodies, incidence of erythropoietin (EPO) 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: PHASE2
Enrollment: 150
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-06-24
Completion Date: 2020-12-30
Results First Posted:
Last Update Posted: 2020-03-09
Locations: The general hospital of the people's liberation army, Beijing, Beijing, 100000, China
URL: https://clinicaltrials.gov/show/NCT03950687