To evaluate the safety, pharmacokinetics, and pharmacodynamics in nondialysis (ND) and hemodialysis (HD) subjects with Chronic Kidney Disease (CKD) who receive a single administration of TS-143.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
29
Taisho Pharmaceutical Co., Ltd selected site
Tokyo and Other Japanese City, Japan
Incidence of adverse events
To evaluate the safety of TS-143 given single administration in CKD patients by incidence of adverse events which include abnormal electrocardiograms, vital signs, and clinical laboratory parameters.
Time frame: 8 days
Plasma concentrations of unchanged form (ng/mL)
The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) were calculated by dose group and evaluation timing.
Time frame: 7 days
Urinary excretions of unchanged form (ng/mL)
The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) for the total urinary excretion (amount and fraction) were summarized by dose group.
Time frame: 24 hours
Serum EPO concentration
Time frame: 4 days
Reticulocyte count
Time frame: 7 days
Plasma vascular endothelial growth factor (VEGF) concentration
Time frame: 4 days
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