The purpose of this study is to evaluate the safety,efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple intravenous doses of EPO-018B in participants with chronic kidney disease (CKD) Who are not on dialysis
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGPercentage of participants who achieved a target hemoglobin response during the study
A target hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) from baseline and a hemoglobin value ≥ 10.0 g/dL during the study
Time frame: Baseline to Week 24
Percentage of participants who response to study drug
Hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) from baseline during the study
Time frame: Baseline to Week 24
Average reticulocytes change from baseline
Time frame: Baseline to Week 24
Average hemoglobin change from baseline
Time frame: Baseline to Week 24
Incidence of adverse events
Time frame: Baseline to Week 24
Incidence of serious adverse events
Time frame: Baseline to Week 24
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