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CompletedNCT01895322Updated Jan 1, 2016Results posted

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

A Phase 2 interventional study of OPC-41061 in Chronic Renal Failure, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 6 sites in Japan. Per ClinicalTrials.gov, last updated 2016-01-01.

Sponsored by Otsuka Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Renal Failure

Keywords

  • Tolvaptan
  • dialysis
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 20 is below the median of 43 across 1,503 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients diagnosed with chronic renal failure
  • Patients who are undergoing peritoneal dialysis (continuous ambulatory peritoneal dialysis [CAPD])

  • Patients who, after undergoing peritoneal dialysis, received any of the following medical treatments for fluid overload [OR: hypervolemia] that had insufficient effect:

    • Addition or increase of diuretics
    • Increase in concentration or volume of peritoneal dialysis fluid
    • Increase in the number of changes of peritoneal dialysis fluid
  • Subjects who, together with their partner, are able to practice one of the specified contraceptive methods until 4 weeks after the final trial drug administration
  • Subjects who are inpatients or who can be admitted to the trial site for the duration of the trial period

Exclusion criteria

Exclusion Criteria:

  • Subjects with any of the following diseases, complications, or symptoms:

    • Suspected hypovolemia
    • Daily urine volume less than 200 mL
    • Urination impaired due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
    • Cardiac function of NYHA class 4

  • Subjects with any of the following medical histories:

    • History of cerebrovascular disorder or coronary artery disease within 4 weeks prior to informed consent
    • History of hypersensitivity or idiosyncratic reaction to benzazepine derivatives such as mozavaptan hydrochloride or benazepril hydrochloride
  • Subjects with any of the following abnormal laboratory values:

Hemoglobin lower than 9.0 g/dL, total bilirubin higher than 3.0 g/dL, ALT (GPT) or AST (GOT) 2 times the upper limit of the reference range of the trial site, serum sodium higher than the upper limit of the reference range of the trial site, serum sodium lower than 125 mEq/L, or serum potassium higher than 5.5 mEq/L

  • Subjects with any of the following conditions, concomitant diseases, or symptoms:

    • defect in diaphragm
    • hemorrhagic diathesis due to uremia
    • suspected lactic acid metabolic disorder
    • suspected peritonitis, peritoneal damage, peritoneal adhesion, or disorders in intraabdominal organs
  • Subjects who have undergone peritoneal dialysis for 8 years or longer
  • Subjects who are scheduled to undergo hemodialysis or concomitant use of hemodialysis, or renal transplantation
  • Subjects who have participated in any other clinical trial or post-marketing clinical studies within 30 days prior to informed consent
  • Subjects who have previously received OPC-41061
  • Subjects who are unable to sense thirst or who have difficulty with fluid or food intake
  • Female subjects who are pregnant, possibly pregnant, or nursing, or who plan to become pregnant during the trial period
  • Subjects otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    OPC-41061

    Drug: OPC-41061

Interventions

  • DrugOPC-41061
06

What researchers measure

Primary outcomes

  1. 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.

  2. 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>

Secondary outcomes

  1. 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

  2. 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)>

07

Results

Posted Jan 1, 2016

Participant flow

Participant flow — Overall Study
MilestoneOPC-41061
Started20
Completed7
Not completed13
Withdrew: Adverse event1
Withdrew: Withdrawal by subject2
Withdrew: Protocol violation10

Outcome measures

PrimaryChange 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.
Reported as:
Mean · mL
Change in Daily Urine Volume From Baseline
mLOPC-41061
Change in Daily Urine Volume From Baseline18.3 ± 340.2
SecondaryChange 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
Reported as:
Mean · kg
Change in Body Weight From Baseline
kgOPC-41061
Change in Body Weight From Baseline-0.61 ± 0.84
PrimaryPercent 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>
Reported as:
Mean · Percentage
Percent Change in Daily Urine Volume From Baseline
PercentageOPC-41061
Percent Change in Daily Urine Volume From Baseline8.89 ± 33.2
SecondaryPercent 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)>
Reported as:
Mean · Percentage
Percent Change in Body Weight
PercentageOPC-41061
Percent Change in Body Weight-0.92 ± 1.31

Adverse events

Collected over daily for 13 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
OPC-41061—0/20 (0%)13/20 (65%)
Most frequent other events
Most frequent other events
EventOPC-41061
ConstipationGastrointestinal disorders4/20
Blood sodium decreasedInvestigations4/20
Nephrogenic anaemiaBlood and lymphatic system disorders3/20
ThirstGeneral disorders3/20
NasopharyngitisInfections and infestations2/20
HyponatraemiaMetabolism and nutrition disorders2/20
PruritusSkin and subcutaneous tissue disorders2/20

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)OPC-41061
<=18 years0
Between 18 and 65 years8
>=65 years12
Age, Continuous
Age, Continuous(years)OPC-41061
Mean65.1 ± 10.9
Sex: Female, Male
Sex: Female, Male(Participants)OPC-41061
Female12
Male8
Region of Enrollment
Region of Enrollment(participants)OPC-41061
Japan20
08

Study locations

6 sites
  • Chubu Region, Japan
  • Hokkaido Region, Japan
  • Kanto Region, Japan
  • Kyushu Region, Japan
  • Shikoku Region, Japan
  • Tohoku Region, Japan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01895322
Lead sponsor
Otsuka Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jul 10, 2013
Start date
Jul 2013
Primary completion
Feb 2014
Completion
Aug 2014
Results posted
Jan 1, 2016
Last update
Jan 1, 2016

Study contacts

Kyoji Imaoka, Mr
study director · Otsuka Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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