Trial Outcomes & Findings for Open-label Dose-finding Trial of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis (NCT NCT01895322)

Results Overview

Change in daily urine volume from baseline during the repeated-administration period (For five days).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period.

Results posted on

2016-01-01

Participant Flow

Participant milestones

Participant milestones
Measure	OPC-41061 In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial. \- 7.5, 15, 30, 60 mg/day (up to a total of 8 days) OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period.
Overall Study STARTED	20
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	OPC-41061 In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial. \- 7.5, 15, 30, 60 mg/day (up to a total of 8 days) OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	2
Overall Study Protocol Violation	10

Baseline Characteristics

Open-label Dose-finding Trial of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OPC-41061 n=20 Participants In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial. \- 7.5, 15, 30, 60 mg/day (up to a total of 8 days) OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=93 Participants
Age, Categorical >=65 years	12 Participants n=93 Participants
Age, Continuous	65.1 years STANDARD_DEVIATION 10.9 • n=93 Participants
Sex: Female, Male Female	12 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Region of Enrollment Japan	20 participants n=93 Participants

PRIMARY outcome

Timeframe: Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period.

Change in daily urine volume from baseline during the repeated-administration period (For five days).

Outcome measures

Outcome measures
Measure	OPC-41061 n=7 Participants In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial. \- 7.5, 15, 30, 60 mg/day (up to a total of 8 days) OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period.
Change in Daily Urine Volume From Baseline	18.3 mL Standard Deviation 340.2

PRIMARY outcome

Timeframe: 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>

Percent change in daily urine volume from baseline during the repeated-administration period (For five days).

Outcome measures

Outcome measures
Measure	OPC-41061 n=7 Participants In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial. \- 7.5, 15, 30, 60 mg/day (up to a total of 8 days) OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period.
Percent Change in Daily Urine Volume From Baseline	8.89 Percentage Standard Deviation 33.2

SECONDARY outcome

Timeframe: Body weight on day13 minus Body weight at baseline(day9) on the repeated-administration period

Change in body weight from baseline during the repeated-administration period(For five days).

Outcome measures

Outcome measures
Measure	OPC-41061 n=7 Participants In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial. \- 7.5, 15, 30, 60 mg/day (up to a total of 8 days) OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period.
Change in Body Weight From Baseline	-0.61 kg Standard Deviation 0.84

SECONDARY outcome

Timeframe: 100%*<Body weight on day13 minus Body weight at baseline (day9)/Body weight at baseline(day9)>

Percent change in body weight from baseline during the repeated-administration period(For five days).

Outcome measures

Outcome measures
Measure	OPC-41061 n=7 Participants In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial. \- 7.5, 15, 30, 60 mg/day (up to a total of 8 days) OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period.
Percent Change in Body Weight	-0.92 Percentage Standard Deviation 1.31

Adverse Events

OPC-41061

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	OPC-41061 n=20 participants at risk OPC-41061
Blood and lymphatic system disorders Nephrogenic anaemia	15.0% 3/20 • Number of events 3 • daily for 13 days
Gastrointestinal disorders Constipation	20.0% 4/20 • Number of events 4 • daily for 13 days
General disorders Thirst	15.0% 3/20 • Number of events 3 • daily for 13 days
Infections and infestations Nasopharyngitis	10.0% 2/20 • Number of events 2 • daily for 13 days
Investigations Blood sodium decreased	20.0% 4/20 • Number of events 4 • daily for 13 days
Metabolism and nutrition disorders Hyponatraemia	10.0% 2/20 • Number of events 2 • daily for 13 days
Skin and subcutaneous tissue disorders Pruritus	10.0% 2/20 • Number of events 2 • daily for 13 days

Additional Information

Director of Clinical Research and Development

Otsuka Pharmaceutical Co., Ltd

Phone: +81-3-6361-7366

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place