Trial · NCT00841568
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]
NCT00841568, Phase 2, 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) [Extension of Study 156-04-001]. Trials, record NCT00841568. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00841568
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) [Extension of Study 156-04-001]
- NCT number
- NCT00841568
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Autosomal Dominant Polycystic Kidney Disease
- Interventions
- OPC-41061
- First posted
- 2009-02-11
- 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 24, 52, 104, and 156 | 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. 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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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 24, 48, 104, and 156 | 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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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 24, 52, 104, and 156 | mL | MEDIAN | |
| PRIMARY | Renal Function Test (eGFR) | Baseline, Week 24, 48, 104, and 156 | mL/min/1.73m2 | 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 | 1500.5 | Inter-Quartile Range 781.5 to 5060.1 | mL | |
| Total Kidney Volume | Week 24 | 1573.1 | Inter-Quartile Range 770.0 to 5036.6 | mL | |
| Total Kidney Volume | Week 52 | 1567.9 | Inter-Quartile Range 774.2 to 4940.3 | mL | |
| Total Kidney Volume | Week 104 | 1729.4 | Inter-Quartile Range 858.4 to 4869.0 | mL | |
| Total Kidney Volume | Week 156 | 1647.7 | Inter-Quartile Range 868.0 to 2563.8 | mL | |
| Renal Function Test (eGFR) | Baseline | 63.0 | Inter-Quartile Range 33 to 108 | mL/min/1.73m2 | |
| Renal Function Test (eGFR) | Week 24 | 64.0 | Inter-Quartile Range 29 to 115 | mL/min/1.73m2 | |
| Renal Function Test (eGFR) | Week 52 | 64.0 | Inter-Quartile Range 35 to 122 | mL/min/1.73m2 | |
| Renal Function Test (eGFR) | Week 104 | 58.5 | Inter-Quartile Range 35 to 114 | mL/min/1.73m2 | |
| Renal Function Test (eGFR) | Week 156 | 59.0 | Inter-Quartile Range 27 to 103 | mL/min/1.73m2 |
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 | 17 | |
| Overall Study | COMPLETED | OPC-41061 | 12 | |
| Overall Study | NOT COMPLETED | OPC-41061 | 5 |
Source ClinicalTrials.gov
Adverse events130
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 | 17 | |
| other | Arrhythmia | Cardiac disorders | OPC-41061 | 1 | 17 | |
| other | Palpitations | Cardiac disorders | OPC-41061 | 3 | 17 | |
| other | Sinus bradycardia | Cardiac disorders | OPC-41061 | 1 | 17 | |
| other | Vertigo | Ear and labyrinth disorders | OPC-41061 | 3 | 17 | |
| other | Asthenopia | Eye disorders | OPC-41061 | 1 | 17 | |
| other | Conjunctival haemorrhage | Eye disorders | OPC-41061 | 1 | 17 | |
| other | Conjunctivitis | Eye disorders | OPC-41061 | 1 | 17 | |
| other | Keratitis | Eye disorders | OPC-41061 | 2 | 17 | |
| other | Eye pruritus | Eye disorders | OPC-41061 | 1 | 17 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OPC-41061 | 1 | 17 |
| Total, other adverse events | OPC-41061 | 17 | 17 |
| Total, serious adverse events | OPC-41061 | 2 | 17 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00841568
GET https://conductscience.org/api/trials/v1/NCT00841568/events?page=2