Trial Outcomes & Findings for 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 (NCT NCT01876381)
NCT ID: NCT01876381
Last Updated: 2018-08-24
Results Overview
The daily urine volume at each timepoint and its change and the percent change from baseline will be summarized with descriptive statistics (number, mean, standard deviation \[SD\], minimum, median, maximum \[same for following parameters\]).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Baseline and Day 14 (Intermittent Administration Period)
Results posted on
2018-08-24
Participant Flow
Participant milestones
| Measure |
OPC-41061
Dose-titration period Administration of OPC-41061 will be started at 7.5 mg/day and the dose was increased stepwise up to as high as 60 mg/day until the dose for intermittent administration is determined. (If the dose was not fixed, the subject received the next higher dose following a 6-day washout period.) Intermittent administration period Subjects received once-daily 4-day intermittent administration of OPC-41061 (days on which hemodialysis or hemodiafiltration was not performed).
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|---|---|
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Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
OPC-41061
Dose-titration period Administration of OPC-41061 will be started at 7.5 mg/day and the dose was increased stepwise up to as high as 60 mg/day until the dose for intermittent administration is determined. (If the dose was not fixed, the subject received the next higher dose following a 6-day washout period.) Intermittent administration period Subjects received once-daily 4-day intermittent administration of OPC-41061 (days on which hemodialysis or hemodiafiltration was not performed).
|
|---|---|
|
Overall Study
Lack of Efficacy
|
5
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
OPC-41061
n=23 Participants
Dose-titration period Administration of OPC-41061 will be started at 7.5 mg/day and the dose was increased stepwise up to as high as 60 mg/day until the dose for intermittent administration is determined. (If the dose was not fixed, the subject received the next higher dose following a 6-day washout period.) Intermittent administration period Subjects received once-daily 4-day intermittent administration of OPC-41061 (days on which hemodialysis or hemodiafiltration was not performed).
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 14 (Intermittent Administration Period)The daily urine volume at each timepoint and its change and the percent change from baseline will be summarized with descriptive statistics (number, mean, standard deviation \[SD\], minimum, median, maximum \[same for following parameters\]).
Outcome measures
| Measure |
OPC-41061
n=16 Participants
Dose-titration period Administration of OPC-41061 will be started at 7.5 mg/day and the dose was increased stepwise up to as high as 60 mg/day until the dose for intermittent administration is determined. (If the dose was not fixed, the subject received the next higher dose following a 6-day washout period.) Intermittent administration period Subjects received once-daily 4-day intermittent administration of OPC-41061 (days on which hemodialysis or hemodiafiltration was not performed).
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|---|---|
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Change From Baseline in Daily Urine Volume
|
481.0 ml
Standard Deviation 427.1
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SECONDARY outcome
Timeframe: Baseline (pretreatment observation period) and Intermittent Administration Period (Day 10 to Day 15)The total volume of fluid removed per week by dialysis at each timepoint and its change from baseline will be summarized with descriptive statistics.
Outcome measures
| Measure |
OPC-41061
n=16 Participants
Dose-titration period Administration of OPC-41061 will be started at 7.5 mg/day and the dose was increased stepwise up to as high as 60 mg/day until the dose for intermittent administration is determined. (If the dose was not fixed, the subject received the next higher dose following a 6-day washout period.) Intermittent administration period Subjects received once-daily 4-day intermittent administration of OPC-41061 (days on which hemodialysis or hemodiafiltration was not performed).
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|---|---|
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Change From Baseline in Total Fluid Removal Per Week by Dialysis
|
-1425.0 ml
Standard Deviation 2139.7
|
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
| Measure |
OPC-41061
n=23 participants at risk
Dose-titration period Administration of OPC-41061 will be started at 7.5 mg/day and the dose was increased stepwise up to as high as 60 mg/day until the dose for intermittent administration is determined. (If the dose was not fixed, the subject received the next higher dose following a 6-day washout period.) Intermittent administration period Subjects received once-daily 4-day intermittent administration of OPC-41061 (days on which hemodialysis or hemodiafiltration was not performed).
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|---|---|
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General disorders
Thirst
|
13.0%
3/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
General disorders
Malaise
|
8.7%
2/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
General disorders
Injection site erosion
|
4.3%
1/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
General disorders
Pyrexia
|
4.3%
1/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
General disorders
Vessel puncture site pain
|
4.3%
1/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
General disorders
Vessel puncture site pruritus
|
4.3%
1/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
2/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
Infections and infestations
Periodontitis
|
4.3%
1/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
Infections and infestations
Urinary tract infection
|
4.3%
1/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
Infections and infestations
Oral herpes
|
4.3%
1/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
8.7%
2/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
Injury, poisoning and procedural complications
Excoriation
|
4.3%
1/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
4.3%
1/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
Investigations
Blood pressure increased
|
4.3%
1/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
Investigations
Blood urine present
|
4.3%
1/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.7%
2/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
2/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
1/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
4.3%
1/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
Renal and urinary disorders
Pollakiuria
|
8.7%
2/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.3%
1/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
1/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
|
Vascular disorders
Hypotension
|
4.3%
1/23 • From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15)
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7366
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place