Trial · NCT01022424
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
NCT01022424, Phase 3, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2018-07-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]. Trials, record NCT01022424. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01022424
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
- NCT number
- NCT01022424
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 13 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Autosomal Dominant Polycystic Kidney Disease
- Interventions
- OPC-41061
- First posted
- 2009-12-01
- Last updated
- 2018-09-11
- Results first posted
- 2018-07-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Kidney Volume | Baseline, Week 48, 96, 144, and 192 | Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period. Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded. |
| Primary | Renal Function Test (eGFR) | Baseline, Week 48, 96, 144, and 192 | Individual subject data on eGFR (estimated glomerular filtration rate calculated by Japanese eGFR equation) during trial period. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded. |
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 | Total Kidney Volume | Baseline, Week 48, 96, 144, and 192 | mL | MEDIAN | |
| PRIMARY | Renal Function Test (eGFR) | Baseline, Week 48, 96, 144, and 192 | mL/min/1.73 m2 | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Kidney Volume | Baseline | 1428 | Inter-Quartile Range 789 to 4774 | mL | |
| Total Kidney Volume | Week 48 | 1675 | Inter-Quartile Range 786 to 4457 | mL | |
| Total Kidney Volume | Week 96 | 1728 | Inter-Quartile Range 791 to 4193 | mL | |
| Total Kidney Volume | Week 144 | 1775 | Inter-Quartile Range 818 to 4125 | mL | |
| Total Kidney Volume | Week 192 | 1901 | Inter-Quartile Range 837 to 3669 | mL | |
| Renal Function Test (eGFR) | Baseline | 63.0 | Inter-Quartile Range 31.0 to 93.0 | mL/min/1.73 m2 | |
| Renal Function Test (eGFR) | Week 48 | 60.0 | Inter-Quartile Range 23.0 to 92.0 | mL/min/1.73 m2 | |
| Renal Function Test (eGFR) | Week 96 | 54.0 | Inter-Quartile Range 22.0 to 113.0 | mL/min/1.73 m2 | |
| Renal Function Test (eGFR) | Week 144 | 50.5 | Inter-Quartile Range 15.0 to 63.0 | mL/min/1.73 m2 | |
| Renal Function Test (eGFR) | Week 192 | 51.0 | Inter-Quartile Range 16.0 to 64.0 | mL/min/1.73 m2 |
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 | 13 | |
| Overall Study | COMPLETED | OPC-41061 | 9 | |
| Overall Study | NOT COMPLETED | OPC-41061 | 4 |
Source ClinicalTrials.gov
Adverse events123
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 | Anaemia | Blood and lymphatic system disorders | OPC-41061 | 1 | 13 | |
| other | Nephrogenic anaemia | Blood and lymphatic system disorders | OPC-41061 | 1 | 13 | |
| other | Sinus tachycardia | Cardiac disorders | OPC-41061 | 1 | 13 | |
| other | Supraventricular extrasystoles | Cardiac disorders | OPC-41061 | 1 | 13 | |
| other | Ventricular extrasystoles | Cardiac disorders | OPC-41061 | 1 | 13 | |
| other | Tinnitus | Ear and labyrinth disorders | OPC-41061 | 1 | 13 | |
| other | Angle closure glaucoma | Eye disorders | OPC-41061 | 1 | 13 | |
| other | Asthenopia | Eye disorders | OPC-41061 | 1 | 13 | |
| other | Cataract | Eye disorders | OPC-41061 | 1 | 13 | |
| other | Conjunctival haemorrhage | Eye disorders | OPC-41061 | 1 | 13 |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OPC-41061 | 0 | 13 |
| Total, other adverse events | OPC-41061 | 13 | 13 |
| Total, serious adverse events | OPC-41061 | 6 | 13 |
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/NCT01022424
GET https://conductscience.org/api/trials/v1/NCT01022424/events?page=2