Conditions: Chronic Renal Failure
Keywords: Tolvaptan dialysis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: OPC-41061
Intervention descriptions: intervention 1: None

Protocol document: