Trial · NCT01895322
Open-label Dose-finding Trial of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis
NCT01895322, Phase 2, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2016-01-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-label Dose-finding Trial of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis. Trials, record NCT01895322. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01895322
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Dose-finding Trial of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis
- NCT number
- NCT01895322
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Chronic Renal Failure
- Interventions
- OPC-41061
- First posted
- 2013-07-10
- Last updated
- 2016-01-01
- Results first posted
- 2016-01-01
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Daily Urine Volume From Baseline | 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). |
| Primary | Percent Change in Daily Urine Volume From Baseline | 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). |
| Secondary | Change in Body Weight From Baseline | 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). |
| Secondary | Percent Change in Body Weight | 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). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Daily Urine Volume From Baseline | Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period. | mL | MEAN | |
| SECONDARY | Change in Body Weight From Baseline | Body weight on day13 minus Body weight at baseline(day9) on the repeated-administration period | kg | MEAN | |
| PRIMARY | Percent Change in Daily Urine Volume From Baseline | 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> | Percentage | MEAN | |
| SECONDARY | Percent Change in Body Weight | 100%*<Body weight on day13 minus Body weight at baseline (day9)/Body weight at baseline(day9)> | Percentage | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Daily Urine Volume From Baseline | OPC-41061 | 18.3 | Standard Deviation 340.2 | mL | |
| Change in Body Weight From Baseline | OPC-41061 | -0.61 | Standard Deviation 0.84 | kg | |
| Percent Change in Daily Urine Volume From Baseline | OPC-41061 | 8.89 | Standard Deviation 33.2 | Percentage | |
| Percent Change in Body Weight | OPC-41061 | -0.92 | Standard Deviation 1.31 | Percentage |
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 | 20 | |
| Overall Study | COMPLETED | OPC-41061 | 7 | |
| Overall Study | NOT COMPLETED | OPC-41061 | 13 |
Source ClinicalTrials.gov
Adverse events7
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 | Nephrogenic anaemia | Blood and lymphatic system disorders | OPC-41061 | 3 | 20 | 3 |
| other | Constipation | Gastrointestinal disorders | OPC-41061 | 4 | 20 | 4 |
| other | Thirst | General disorders | OPC-41061 | 3 | 20 | 3 |
| other | Nasopharyngitis | Infections and infestations | OPC-41061 | 2 | 20 | 2 |
| other | Blood sodium decreased | Investigations | OPC-41061 | 4 | 20 | 4 |
| other | Hyponatraemia | Metabolism and nutrition disorders | OPC-41061 | 2 | 20 | 2 |
| other | Pruritus | Skin and subcutaneous tissue disorders | OPC-41061 | 2 | 20 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OPC-41061 | ||
| Total, other adverse events | OPC-41061 | 13 | 20 |
| Total, serious adverse events | OPC-41061 | 0 | 20 |
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/NCT01895322
GET https://conductscience.org/api/trials/v1/NCT01895322/registered