Trial · NCT02847624
Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD
NCT02847624, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2025-12-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD. Trials, record NCT02847624. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02847624
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD
- NCT number
- NCT02847624
- Status
- Completed
- Enrollment
- 1,802 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Interventions
- tolvaptan
- First posted
- 2016-07-28
- Last updated
- 2025-12-10
- Results first posted
- 2025-12-10
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Estimated Slope of Total Kidney Volume During Pre-administration and Administration | Pre-administration: From the first pre-treatment measurement (up to 12.5 years prior) to the start of tolvaptan. During-treatment: From the start of tolvaptan to the final follow-up (up to 8.0 years later). | Total Kidney Volume (TKV) was used as a biomarker to assess the progression of ADPKD. TKV was measured at each participating site based on imaging obtained via ultrasound, CT, or MRI. The Estimated Slope pre-administration was calculated for subjects who had TKV measurements both prior to and on the day of Tolvaptan initiation (baseline). The rate of change in TKV from the pre-treatment measurement date to the baseline was used to determine the Estimated Slope. Since the date of initiating tolvaptan administration is considered the start date of the study, the kidney volume measured prior to administration falls outside the study period (i.e., it is a value from before the study start date). The Estimated Slope during-treatment was calculated for subjects who had bilateral TKV measurements at baseline and during the treatment period. The rate of change in TKV from baseline to the measurement date during treatment was used to determine the Estimated Slope. |
| Secondary | The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L) | From the date of Tolvaptan initiation to the earlier of either the date when ALT reached three times the upper limit of normal or the date of Tolvaptan discontinuation (up to 2789 days). | Among cases included in the safety analysis, we counted and listed the number of patients whose ALT levels increased after starting tolvaptan but never exceeded three times the upper limit of normal (30 IU/L) at a specific time point (day) during treatment. Cases in which Tolvaptan treatment was discontinued were considered as dropouts on the day of discontinuation. The number of participants analyzed in each row of the data table is the same as the Overall Number of Participants Analyzed (n=1,672) |
| Secondary | The Number of Cases in Which AST Never Exceeded Three Times the Upper Limit of Normal (30 IU/L) | From the date of Tolvaptan initiation to the earlier of either the date when AST reached three times the upper limit of normal or the date of Tolvaptan discontinuation (up to 2789 days). | Among cases included in the safety analysis, we counted and listed the number of patients whose AST levels increased after starting tolvaptan but never exceeded three times the upper limit of normal (30 IU/L) at a specific time point (day) during treatment. Cases in which Tolvaptan treatment was discontinued were considered as dropouts on the day of discontinuation. The number of participants analyzed in each row of the data table is the same as the Overall Number of Participants Analyzed (n=1,672) |
| Other | Estimated Slope of Estimated Glomerular Filtration Rate (e-GFR) During Pre-administration and Administration | Pre-administration: From the first pre-treatment measurement (up to 10 years prior) to the start of tolvaptan. During-treatment: From the start of tolvaptan to the final follow-up (up to 8.0 years later). | e-GFR was used as a biomarker to evaluate ADPKD progression. Values recorded in the CRF were prioritized; if unavailable, e-GFR was calculated using serum creatinine levels with a gender-specific formula. Male: e-GFR=194×(serum creatinine (mg/dL))\^-1.094 ×(age)\^-0.287 Female: e-GFR=\[194×(serum creatinine (mg/dL))\^-1.094 ×(age)\^-0.287\]×0.739 The pre-treatment Estimated Slope was determined for subjects with e-GFR data both before and at the start of tolvaptan administration (baseline). Since the date of initiating tolvaptan administration is considered the start date of the study, the e-GFR measured prior to administration falls outside the study period. The during-treatment Estimated Slope was calculated for subjects with e-GFR measurements at baseline and during treatment, based on the rate of change from baseline to follow-up. |
| Other | The Number and Percentage of Adverse Events Observed in Patients Aged 65 Years and Older | Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years). | The incidence rates of Adverse Drug Reactions(ADRs) were calculated for 192 elderly patients aged 65 years and older, and compared with those in non-elderly patients under 65 years of age. |
| Other | Safety in Patients With Advanced ADPKD | Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years). | Adverse events were summarized in patients with advanced ADPKD who had their creatinine clearance measured at the start of tolvaptan treatment. Patients with advanced ADPKD were defined as those with a pre-treatment creatinine clearance of less than 60 mL/min. The incidence rates of Adverse Drug Reactions(ADRs) were calculated for 752 patients with creatinine clearance \<60 mL/min, 261 patients with clearance between 60 and \<80 mL/min, and 331 patients with clearance ≥80 mL/min, and the rates were compared across the creatinine clearance groups. |
| Other | Safety of Long-term Treatment for ADPKD | Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years). | In the clinical trials conducted prior to approval, there were no cases in which Samsca was administered continuously for more than three years. In this post-marketing surveillance, cases exceeding the three-year (36-month) treatment period of the pre-approval clinical trials were classified as long-term treatment cases. The safety of long-term treatment was evaluated based on the incidence rate of adverse drug reactions (ADRs) according to the timing of their onset. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Estimated Slope of Total Kidney Volume During Pre-administration and Administration | Pre-administration: From the first pre-treatment measurement (up to 12.5 years prior) to the start of tolvaptan. During-treatment: From the start of tolvaptan to the final follow-up (up to 8.0 years later). | Pre-administration: Estimated slope was calculated in cases with both pre-treatment and baseline TKV data.~During-treatment: Estimated slope was calculated in cases with both baseline and on-treatment TKV data.~Because this study used real-world clinical data, not all patients had both sets of measurements required for either group. As a result, the number of cases included in the pre-administration and during-treatment groups was smaller than the total of 1,672 cases analyzed for efficacy. | %/year | MEAN |
| SECONDARY | The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L) | From the date of Tolvaptan initiation to the earlier of either the date when ALT reached three times the upper limit of normal or the date of Tolvaptan discontinuation (up to 2789 days). | Safety analysis population (n = 1,672) | participants | NUMBER |
| SECONDARY | The Number of Cases in Which AST Never Exceeded Three Times the Upper Limit of Normal (30 IU/L) | From the date of Tolvaptan initiation to the earlier of either the date when AST reached three times the upper limit of normal or the date of Tolvaptan discontinuation (up to 2789 days). | Safety analysis population (n = 1,672) | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Estimated Slope of Estimated Glomerular Filtration Rate (e-GFR) During Pre-administration and Administration | Pre-administration: From the first pre-treatment measurement (up to 10 years prior) to the start of tolvaptan. During-treatment: From the start of tolvaptan to the final follow-up (up to 8.0 years later). | Pre-administration: Estimated slope was calculated in cases with both pre-treatment and baseline e-GFR data.~During-treatment: Estimated slope was calculated in cases with both baseline and on-treatment e-GFR data.~Because this study used real-world clinical data, not all patients had both sets of measurements required for either group. As a result, the number of cases included in the pre-administration and during-treatment groups was smaller than the total of 1672 cases analyzed for efficacy. | %/year | MEAN |
| OTHER_PRE_SPECIFIED | The Number and Percentage of Adverse Events Observed in Patients Aged 65 Years and Older | Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years). | Elderly patients: Aged 65 years and older Non-elderly patients: Aged under 65 years | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Safety in Patients With Advanced ADPKD | Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years). | The study cases were divided into the following three groups based on creatinine clearance before administration, and the incidence rate of ADRs was calculated for each group: less than 60 mL/min, 60 to less than 80 mL/min, and 80 mL/min or more. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Safety of Long-term Treatment for ADPKD | Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years). | The incidence rate of ADRs was calculated for each time interval from the start of administration. Cases exceeding 36 months were classified as long-term treatment. In cases where the same ADR occurred multiple times in the same patient, all occurrences were included in the calculation. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Estimated Slope of Total Kidney Volume During Pre-administration and Administration | ADPKD | Pre-administration | 6.7517 | Standard Deviation 0.2183 | %/year |
| Estimated Slope of Total Kidney Volume During Pre-administration and Administration | ADPKD | During administration | 3.6811 | Standard Deviation 0.9514 | %/year |
| The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L) | ADPKD | Baseline | 1672 | participants | |
| The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L) | ADPKD | 500 days | 1210 | participants | |
| The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L) | ADPKD | 1000 days | 1007 | participants | |
| The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L) | ADPKD | 1500 days | 706 | participants | |
| The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L) | ADPKD | 2000 days | 402 | participants | |
| The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L) | ADPKD | 2500 days | 47 | participants | |
| The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L) | ADPKD | 3000 days | 0 | participants | |
| The Number of Cases in Which AST Never Exceeded Three Times the Upper Limit of Normal (30 IU/L) | ADPKD | Baseline | 1672 | participants |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ADPKD | 1,802 | |
| Overall Study | COMPLETED | ADPKD | 1,672 | |
| Overall Study | NOT COMPLETED | ADPKD | 130 |
Source ClinicalTrials.gov
Adverse events77
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 | Pharyngitis | Infections and infestations | ADPKD | 46 | 1,672 | 46 |
| other | Renal Cyst Infection | Infections and infestations | ADPKD | 45 | 1,672 | 45 |
| other | Hyperkalemia | Metabolism and nutrition disorders | ADPKD | 61 | 1,672 | 61 |
| other | Hypernatremia | Metabolism and nutrition disorders | ADPKD | 93 | 1,672 | 93 |
| other | Hyperuricemia | Metabolism and nutrition disorders | ADPKD | 177 | 1,672 | 177 |
| other | Hypertension | Vascular disorders | ADPKD | 50 | 1,672 | 50 |
| other | Constipation | Gastrointestinal disorders | ADPKD | 35 | 1,672 | 35 |
| other | Liver Function Disorder | Hepatobiliary disorders | ADPKD | 178 | 1,672 | 178 |
| other | Liver Disorder | Hepatobiliary disorders | ADPKD | 59 | 1,672 | 59 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | ADPKD | 44 | 1,672 | 44 |
1 to 10 of 77Source ClinicalTrials.gov
See all 77 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ADPKD | 21 | 1,672 |
| Total, other adverse events | ADPKD | 1,086 | 1,672 |
| Total, serious adverse events | ADPKD | 253 | 1,672 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39953249 | 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.
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