Trial · NCT02331680

A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration

NCT02331680, Phase 2, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2019-10-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration. Trials, record NCT02331680. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02331680

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
NCT number: NCT02331680
Status: Completed
Phases: Phase 2
Enrollment: 124 participants, actual
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Conditions: Chronic Renal Failure
Interventions: OPC-41061, OPC-41061, Placebo
First posted: 2015-01-06
Last updated: 2019-10-22
Results first posted: 2019-10-22

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Daily Urine Volume	Baseline，End of the treatment	Change in daily urine volume from baseline to the end of the treatment was calculated using descriptive statistics.
Secondary	Change in Total Volume of Fluid Removed by Dialysis Per Week	Baseline，End of the treatment	Change in total volume of fluid removed by dialysis per week from baseline to the end of the treatment was calculated using descriptive statistics.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Daily Urine Volume	Baseline，End of the treatment		mL	MEAN
SECONDARY	Change in Total Volume of Fluid Removed by Dialysis Per Week	Baseline，End of the treatment		mL	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Daily Urine Volume	OPC-41061 15mg/Day	169.2	Standard Deviation 422.2	mL
Change From Baseline in Daily Urine Volume	OPC-41061 30mg/Day	111.8	Standard Deviation 557.7	mL
Change From Baseline in Daily Urine Volume	Placebo	-259.9	Standard Deviation 463.8	mL
Change in Total Volume of Fluid Removed by Dialysis Per Week	OPC-41061 15mg/Day	485.9	Standard Deviation 1979.3	mL
Change in Total Volume of Fluid Removed by Dialysis Per Week	OPC-41061 30mg/Day	375.4	Standard Deviation 1721.8	mL
Change in Total Volume of Fluid Removed by Dialysis Per Week	Placebo	1099.5	Standard Deviation 2160.5	mL

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	OPC-41061 15mg/Day	40
Overall Study	STARTED	OPC-41061 30mg/Day	40
Overall Study	STARTED	Placebo	44
Overall Study	COMPLETED	OPC-41061 15mg/Day	34
Overall Study	COMPLETED	OPC-41061 30mg/Day	36
Overall Study	COMPLETED	Placebo	29
Overall Study	NOT COMPLETED	OPC-41061 15mg/Day	6
Overall Study	NOT COMPLETED	OPC-41061 30mg/Day	4
Overall Study	NOT COMPLETED	Placebo	15

Source ClinicalTrials.gov

Adverse events129

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nasopharyngitis	Infections and infestations	OPC-41061 15mg/Day	9	39
other	Nasopharyngitis	Infections and infestations	OPC-41061 30mg/Day	14	39
other	Nasopharyngitis	Infections and infestations	Placebo	10	44
other	Folliculitis	Infections and infestations	OPC-41061 15mg/Day	0	39
other	Folliculitis	Infections and infestations	OPC-41061 30mg/Day	2	39
other	Folliculitis	Infections and infestations	Placebo	0	44
other	Contusion	Injury, poisoning and procedural complications	OPC-41061 15mg/Day	1	39
other	Contusion	Injury, poisoning and procedural complications	OPC-41061 30mg/Day	7	39
other	Contusion	Injury, poisoning and procedural complications	Placebo	3	44
other	Shunt stenosis	Injury, poisoning and procedural complications	OPC-41061 15mg/Day	0	39

1 to 10 of 129Source ClinicalTrials.gov

See all 129 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	OPC-41061 15mg/Day	0	39
Total, all-cause mortality	OPC-41061 30mg/Day	0	39
Total, all-cause mortality	Placebo	0	44
Total, other adverse events	OPC-41061 15mg/Day	34	39
Total, other adverse events	OPC-41061 30mg/Day	38	39
Total, other adverse events	Placebo	34	44
Total, serious adverse events	OPC-41061 15mg/Day	6	39
Total, serious adverse events	OPC-41061 30mg/Day	7	39
Total, serious adverse events	Placebo	10	44

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02331680

GET https://conductscience.org/api/trials/v1/NCT02331680/events?page=2

API reference For AI assistants