To investigate the safety, pharmacokinetics, pharmacodynamics, and efficacy of OPC-41061 in patients with chronic renal failure undergoing hemodialysis or hemodiafiltration using variables, such as daily urine volume and increase in interval body weights between hemodialysis or hemodiafiltration, in 4-day intermittant administration (excluding the days of hemodialysis or hemodiafiltration) at the dose fixed during the dose-escalation period
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
The maximum number of days of administration will be 8 days (8 doses) in total 4 days each in the dose-escalation period and intermittant administration period. The investigational medicinal product (IMP) will be administered once daily after breakfast
Unnamed facility
Chube Region, Japan
Unnamed facility
Kanto Region, Japan
Unnamed facility
Kinki Region, Japan
Unnamed facility
Kyushu Region, Japan
Unnamed facility
Tohoku Region, Japan
Change From Baseline in Daily Urine Volume
The daily urine volume at each timepoint and its change and the percent change from baseline will be summarized with descriptive statistics (number, mean, standard deviation \[SD\], minimum, median, maximum \[same for following parameters\]).
Time frame: Baseline and Day 14 (Intermittent Administration Period)
Change From Baseline in Total Fluid Removal Per Week by Dialysis
The total volume of fluid removed per week by dialysis at each timepoint and its change from baseline will be summarized with descriptive statistics.
Time frame: Baseline (pretreatment observation period) and Intermittent Administration Period (Day 10 to Day 15)
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