The purpose of this study is to evaluate the safety and efficacy of multiple intravenous doses of pegol-Sihematide in participants with chronic kidney disease (CKD) who are on dialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Changzheng Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGAverage reticulocytes and hemoglobin change from baseline
Time frame: Baseline to Week 16
Proportion of patients whose Hb within ±1.0 g/dL of baseline during Weeks 12 to 16
Time frame: week 12 to 16
Average RBC, hematokrit and reticulocytes change from baseline
Time frame: Baseline to Week 16
Proportion of patients whose Hb levels were maintained within 10 to 12.0g/dL during Weeks 12 to 16
Time frame: week 12 to 16
Incidence of adverse events and serious adverse events
Time frame: Baseline to Week 16
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