Trial · NCT01280721
A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]
NCT01280721, Phase 3, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2019-01-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]. Trials, record NCT01280721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01280721
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]
- NCT number
- NCT01280721
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 135 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Autosomal Dominant Polycystic Kidney Disease （ADPKD)
- Interventions
- tolvaptan
- First posted
- 2011-01-21
- Last updated
- 2019-01-17
- Results first posted
- 2019-01-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Kidney Volume | Baseline, Month12, Month24, and Month36 | Measured values of total kidney volume (sum of the volume of the left and right kidneys) during trial period. Twice-daily repeated oral administration of tolvaptan at daily doses of 60 to 120 mg. 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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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, Month12, Month24, and Month36 | Estimated glomerular filtration rate calculated by Japanese equation for eGFR 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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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 (Cys-C) | Baseline, Month 12, Month 24, and Month 36 | Measured values of serum cystatin C concentration 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
Outcomes3
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, Month12, Month24, and Month36 | mL | MEAN | |
| PRIMARY | Renal Function Test (eGFR) | Baseline, Month12, Month24, and Month36 | mL/min/1.73 m2 | MEAN | |
| PRIMARY | Renal Function Test (Cys-C) | Baseline, Month 12, Month 24, and Month 36 | mg/L | MEAN |
Source ClinicalTrials.gov
Results by group12
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 | 1812.38 | Standard Deviation 859.21 | mL | |
| Total Kidney Volume | Month 12 | 1878.82 | Standard Deviation 950.60 | mL | |
| Total Kidney Volume | Month 24 | 1934.14 | Standard Deviation 926.79 | mL | |
| Total Kidney Volume | Month 36 | 2214.28 | Standard Deviation 842.87 | mL | |
| Renal Function Test (eGFR) | Baseline | 61.2 | Standard Deviation 21.7 | mL/min/1.73 m2 | |
| Renal Function Test (eGFR) | Month 12 | 56.3 | Standard Deviation 21.7 | mL/min/1.73 m2 | |
| Renal Function Test (eGFR) | Month 24 | 51.8 | Standard Deviation 20.1 | mL/min/1.73 m2 | |
| Renal Function Test (eGFR) | Month 36 | 43.5 | Standard Deviation 20.3 | mL/min/1.73 m2 | |
| Renal Function Test (Cys-C) | Baselime | 1.016 | Standard Deviation 0.421 | mg/L | |
| Renal Function Test (Cys-C) | Month 12 | 1.114 | Standard Deviation 0.477 | mg/L |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tolvaptan | 135 | |
| Overall Study | COMPLETED | Tolvaptan | 113 | |
| Overall Study | NOT COMPLETED | Tolvaptan | 22 |
Source ClinicalTrials.gov
Adverse events118
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 | Iron deficiency anaemia | Blood and lymphatic system disorders | Tolvaptan | 3 | 135 | |
| other | Palpitations | Cardiac disorders | Tolvaptan | 3 | 135 | |
| other | Tachycardia | Cardiac disorders | Tolvaptan | 3 | 135 | |
| other | Ventricular extrasystoles | Cardiac disorders | Tolvaptan | 3 | 135 | |
| other | Congenital cystic kidney disease | Congenital, familial and genetic disorders | Tolvaptan | 3 | 135 | |
| other | Vertigo | Ear and labyrinth disorders | Tolvaptan | 3 | 135 | |
| other | Conjunctival haemorrhage | Eye disorders | Tolvaptan | 5 | 135 | |
| other | Dry eye | Eye disorders | Tolvaptan | 3 | 135 | |
| other | Glaucoma | Eye disorders | Tolvaptan | 3 | 135 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Tolvaptan | 8 | 135 |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tolvaptan | 0 | 135 |
| Total, other adverse events | Tolvaptan | 134 | 135 |
| Total, serious adverse events | Tolvaptan | 20 | 135 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29123425 | DERIVED |
Source PubMed
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/NCT01280721
GET https://conductscience.org/api/trials/v1/NCT01280721/events?page=2