To investigate the efficacy, pharmacokinetics, pharmacodynamics, and safety of OPC-41061 in patients with chronic renal failure who are undergoing peritoneal dialysis, using daily urine volume, body weight, and edematous conditions as parameters and conducting dose escalation every 2 days until reaching the dose that achieves urine volume increase and then performing 5-day repeated administration at the fixed dose, the final dose used in the dose escalation period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Unnamed facility
Chubu Region, Japan
Unnamed facility
Hokkaido Region, Japan
Unnamed facility
Kanto Region, Japan
Unnamed facility
Kyushu Region, Japan
Unnamed facility
Shikoku Region, Japan
Change in Daily Urine Volume From Baseline
Change in daily urine volume from baseline during the repeated-administration period (For five days).
Time frame: Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period.
Percent Change in Daily Urine Volume From Baseline
Percent change in daily urine volume from baseline during the repeated-administration period (For five days).
Time frame: 100%*<Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period/Urine Volume at baseline(day9) on the repeated-administration period>
Change in Body Weight From Baseline
Change in body weight from baseline during the repeated-administration period(For five days).
Time frame: Body weight on day13 minus Body weight at baseline(day9) on the repeated-administration period
Percent Change in Body Weight
Percent change in body weight from baseline during the repeated-administration period(For five days).
Time frame: 100%*<Body weight on day13 minus Body weight at baseline (day9)/Body weight at baseline(day9)>
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Unnamed facility
Tohoku Region, Japan