Trial · NCT01876381
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
NCT01876381, Phase 2, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2018-08-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT01876381. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01876381
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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 number
- NCT01876381
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Chronic Renal Failure
- Interventions
- OPC-41061
- First posted
- 2013-06-12
- Last updated
- 2018-08-24
- Results first posted
- 2018-08-24
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 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 \[same for following parameters\]). |
| Secondary | Change From Baseline in Total Fluid Removal Per Week by Dialysis | 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. |
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 and Day 14 (Intermittent Administration Period) | ml | MEAN | |
| SECONDARY | Change From Baseline in Total Fluid Removal Per Week by Dialysis | Baseline (pretreatment observation period) and Intermittent Administration Period (Day 10 to Day 15) | ml | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Daily Urine Volume | OPC-41061 | 481.0 | Standard Deviation 427.1 | ml | |
| Change From Baseline in Total Fluid Removal Per Week by Dialysis | OPC-41061 | -1425.0 | Standard Deviation 2139.7 | ml |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OPC-41061 | 23 | |
| Overall Study | COMPLETED | OPC-41061 | 16 | |
| Overall Study | NOT COMPLETED | OPC-41061 | 7 |
Source ClinicalTrials.gov
Adverse events23
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 | Events |
|---|---|---|---|---|---|---|
| other | Thirst | General disorders | OPC-41061 | 3 | 23 | |
| other | Malaise | General disorders | OPC-41061 | 2 | 23 | |
| other | Injection site erosion | General disorders | OPC-41061 | 1 | 23 | |
| other | Pyrexia | General disorders | OPC-41061 | 1 | 23 | |
| other | Vessel puncture site pain | General disorders | OPC-41061 | 1 | 23 | |
| other | Vessel puncture site pruritus | General disorders | OPC-41061 | 1 | 23 | |
| other | Nasopharyngitis | Infections and infestations | OPC-41061 | 2 | 23 | |
| other | Periodontitis | Infections and infestations | OPC-41061 | 1 | 23 | |
| other | Urinary tract infection | Infections and infestations | OPC-41061 | 1 | 23 | |
| other | Oral herpes | Infections and infestations | OPC-41061 | 1 | 23 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OPC-41061 | 0 | 23 |
| Total, other adverse events | OPC-41061 | 13 | 23 |
| Total, serious adverse events | OPC-41061 | 0 | 23 |
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.
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/NCT01876381
GET https://conductscience.org/api/trials/v1/NCT01876381/events?page=2