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Clinical Trial Details

Trial ID: L0047
Source ID: NCT03902691
Associated Drug: Pegol-Sihematide
Title: Study of the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With Chronic Kidney Disease on Dialysis
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases
Interventions: DRUG: Pegol-Sihematide|DRUG: ESPO
Outcome Measures: Primary: The mean change from the baseline hemoglobin level to the mean level during the evaluation period, The primary efficacy end point is the mean change from the baseline hemoglobin level to the mean level during the evaluation period. The baseline hemoglobin value is defined as the mean of three hemoglobin values: the 4 weeks and 2 weeks recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the evaluation period was calculated as the mean of all available hemoglobin values during that period. Hemoglobin measurements will be performed at baseline and thereafter every 2 weeks (for the dose adjustment and the evaluation periods) or every 4 weeks (for the extensional treatment period)., Week 17-24 | Secondary: Proportion of Patients Whose Hemoglobin Within ±1.0 g/dL of Baseline during the Evaluation Period, The hemoglobin value within ±1.0 g/dL of baseline is defined as the difference between the hemoglobin value and the baseline value in the 4 tests in the Evaluation Period was at least 3 times between 1.0g /dL. The Evaluation Period is defined as study weeks 17 through 24., Week 17-24|Mean Dose of Participants With Hemoglobin Within ±1.0 g/dL of Baseline during the Evaluation Period, Mean dose was calculated at least 3 times from measurements taken during the Evaluation Period (Week 17 to Week 24)., Week 17-24|Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period, The hemoglobin value within the target range of 10.0 to 12.0 g/dL during the evaluation period is defined as HGB values were between 10.0 and 12.0 g/dL in at least 3 of the 4 tests in the efficacy evaluation period., Week 17-24|Average Hemoglobin, RBC, hematokrit and reticulocytes change from baseline, The baseline hemoglobin value is defined as the mean of three hemoglobin values: the 4 weeks and 2 weeks recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization., Week 0-52 | Other: Safety Outcome Measures: adverse events, The incidence of patients who reported serious adverse events (SAE), Week 0-52|Safety Outcome Measures: composite safety endpoint(CSE), The incidence of patients with risk cardiovascular events, The CSE consisted of five events: death, stroke, myocardial infarction, and serious adverse events of congestive heart failure and unstable angina. An independent Clinical Endpoint Committee (CEC) was used to provide blinded adjudication of potential CSE events., Week 0-52|Safety Outcome Measures: antibody, The incidence of patients with antibody to Pegol-Sihematide., Week 17-24
Sponsor/Collaborators: Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 372
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2019-05-15
Completion Date: 2022-05-30
Results First Posted:
Last Update Posted: 2023-03-09
Locations: The First Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, 310000, China
URL: https://clinicaltrials.gov/show/NCT03902691