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Clinical Trial Details

Trial ID: L0628
Source ID: NCT04231292
Associated Drug: Rd01
Title: A Phase 2 Clinical Study of Pegerythropoietin Injection (RD01) for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Patient of Anemia in Chronic Renal Failure With Hemodialysis
Interventions: DRUG: RD01|DRUG: Recombinant Human Erythropoiesis Injection (CHO cell)|DRUG: placebo
Outcome Measures: Primary: Primary efficacy index : The change of hemoglobin concentration of experimental group from baseline to the end of 4th and 6th week, Day 1~4th week & Day 1~6th week|Primary efficacy index: The difference of hemoglobin concentration between the experimental group and the placebo group at the end of 4th and 6th week;, Day 1~4th week & Day 1~6th week|Primary efficacy index: hemoglobin concentration change from baseline to the end of first stage, The amount of change in hemoglobin concentration from baseline to the end of the first stage, Day 1~18th week|Primary efficacy index: hemoglobin concentration change from baseline to the evaluation periods in the second stage (39th ~46th week), The amount of change in hemoglobin concentration from baseline to the evaluation periods in the second stage (39th \~46th week)., Day 1~ evaluation periods (39th ~46th week) | Secondary: Secondary efficacy index: the optimal dosage, The optimal dosage of the subjects at the end of the first stage and the evaluation period (39th \~46th week) in the second stage, the end of 18th week & 39th ~46th week|Secondary efficacy index: maintenance rate, the proportion of subjects whose average Hb concentration remain within the target range during the evaluation period, 39th-46th week|Secondary efficacy index : Proportion of subjects with unstable Hb during the evaluation period, 39th-46th week|Secondary efficacy index: proportion of times of Hb remains within the target range, the proportion of times the measured Hb concentration remains within the target range during the evaluation period;, 39th-46th week|Secondary efficacy index: EPO dose conversion coefficient of RD01, EPO dose conversion factor for subjects at the end of the first stage and evaluation periods in the second stage, end of 18th week & 39th ~46th week|Safety indicator: adverse events, the type, proportion and severity of adverse events, for 46 weeks|Immunogenicity indicator: incidence of anti-RD01 antibodies, incidence of anti-RD01 antibodies, for 46 weeks|Maximum Plasma Concentration (Cmax), the Cmax of RD01 in patients with long-term medication., for 46 weeks|Area Under the Curve (AUC), the AUC of RD01 in patients with long-term medication., for 46 weeks
Sponsor/Collaborators: Sponsor: Shengzhen Sciprogen Bio-pharmaceutical Co. Ltd
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 105
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2020-03-01
Completion Date: 2022-12-31
Results First Posted:
Last Update Posted: 2020-01-18
Locations: Renal Rheumatology and Immunology department Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, 200092, China
URL: https://clinicaltrials.gov/show/NCT04231292