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Clinical Trial Details

Trial ID: L0670
Source ID: NCT04502537
Associated Drug: Roxadustat
Title: Roxadustat for Anemia in Patients With CKD
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Anemia of Chronic Kidney Disease
Interventions: DRUG: Roxadustat|DRUG: erythropoietin
Outcome Measures: Primary: Mean value of Hb levels over time, Hb will be measured throughout the period., Up to Week 52|Achievement rate for target Hb level, Percent of participants who achieved target Hb level (≥10.0 )., Up to Week 52 | Secondary: Mean Hb levels at 4 weeks after using roxadustat, Hb levels at 4 weeks after using roxadustat, At Week 4|Mean Hb levels at 8 weeks after using roxadustat, Hb levels at 8 weeks after using roxadustat, At Week 8|the dose of Roxadustat used, the dose of Roxadustat used recorded monthly, Up to Week 52|Change from baseline in Hemoglobin (Hb) levels, Change from baseline in Hemoglobin (Hb) levels was recorded monthly, Up to Week 52|the proportion of patients with different Hb levels, the proportion of patients with different Hb levels, Up to Week 52|The proportion of patients with low response to ESA, The proportion of patients with low response to ESA, Up to Week 52|Concentration of Serum iron, Serum iron will be measured throughout the period., Up to Week 52|Number of Participants with adverse events, adverse events will be record throughout the period., Up to Week 52
Sponsor/Collaborators: Sponsor: Shenzhen Second People's Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 200
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2021-02-01
Completion Date: 2023-09-30
Results First Posted:
Last Update Posted: 2021-01-22
Locations: Shenzhen Second People's Hospital, Shenzhen, China
URL: https://clinicaltrials.gov/show/NCT04502537