This is a study to investigate the efficacy and safety of OPC-41061 by 24-week oral administration of OPC-41061 at 15-mg or 30-mg or placebo in patients with chronic renal failure who are undergoing hemodialysis or hemodiafiltration and who have daily urine volume of at least 500 mL/day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
124
Unnamed facility
Kanto, Region, Japan
Unnamed facility
Kinki, Region, Japan
Unnamed facility
Kyushu, Region, Japan
Unnamed facility
Tōhoku, Region, Japan
Change From Baseline in Daily Urine Volume
Change in daily urine volume from baseline to the end of the treatment was calculated using descriptive statistics.
Time frame: Baseline,End of the treatment
Change in Total Volume of Fluid Removed by Dialysis Per Week
Change in total volume of fluid removed by dialysis per week from baseline to the end of the treatment was calculated using descriptive statistics.
Time frame: Baseline,End of the treatment
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