A Phase 2, Multi-center, Open-label, Dose-finding Trial to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of OPC-41061 in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration

PHASE2CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

February 28, 2014

Study Completion Date

February 28, 2014

Conditions
Chronic Renal Failure
Interventions
DRUG

OPC-41061

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

Trial Locations (5)

Unknown

Chube Region

Kanto Region

Kinki Region

Kyushu Region

Tohoku Region

All Listed Sponsors
lead

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY