Trial · NCT01336972
Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
NCT01336972, Phase 2, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2017-06-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD). Trials, record NCT01336972. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01336972
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- NCT number
- NCT01336972
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Autosomal Dominant Polycystic Kidney Disease
- Interventions
- Tolvaptan
- First posted
- 2011-04-18
- Last updated
- 2019-03-05
- Other registries' IDs
- eudract:2010-019025-33
- Results first posted
- 2017-06-28
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Measured Glomerular Filtration Rate (mGFR) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. | After 3 weeks of treatment and 3 weeks post treatment | Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours). The mGFR was corrected for voiding errors. |
| Primary | Mean Change From Baseline in Effective Renal Plasma Flow (ERPF) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. | After 3 weeks of treatment and 3 weeks post treatment | Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours). |
| Primary | Mean Change From Baseline in Filtration Fraction (GFR/ERFP) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. | After 3 weeks of treatment and 3 weeks post treatment | Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours). |
| Secondary | Mean Change From Baseline in Free Water Clearance After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment | After 3 weeks of treatment and 3 weeks post treatment | Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours). |
| Secondary | Time to Peak Plasma Concentration (Cmax) After 3 Weeks of Tolvaptan Treatment. | Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hour | Blood sampling for determination of tolvaptan concentrations took place at the Baseline, Final Treatment, and the Post Treatment or Early Termination visits. At the Final Treatment visit (Day 21 \[+/- 1 day)\]), blood samples were collected prior to the start of infusion of study treatment and at 1, 2, 3, 4, and 5 hours postdose. At the Baseline (Day 0), and Post Treatment visit (3 weeks \[+/-3 days\] after last dose), a blood sample was collected prior to the start of infusion of study treatment. |
| Secondary | Time to Peak Plasma Concentration (Tmax) After 3 Weeks of Tolvaptan Treatment. | Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hour | Blood sampling for determination of tolvaptan concentrations took place at the Baseline, Final Treatment, and the Post Treatment or Early Termination visits. At the Final Treatment visit (Day 21 \[+/- 1 day)\]), blood samples were collected prior to the start of infusion of study treatment and at 1, 2, 3, 4, and 5 hours postdose. At the Baseline (Day 0), and Post Treatment visit (3 weeks \[+/-3 days\] after last dose), a blood sample was collected prior to the start of infusion of study treatment. |
| Secondary | Area Under the Concentration-time Curve From 0 to 5 Hours (AUC0-5) After 3 Weeks of Tolvaptan Treatment. | Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hour | Blood sampling for determination of tolvaptan concentrations took place at the Baseline, Final Treatment, and the Post Treatment or Early Termination visits. At the Final Treatment visit (Day 21 \[+/- 1 day)\]), blood samples were collected prior to the start of infusion of study treatment and at 1, 2, 3, 4, and 5 hours postdose. At the Baseline (Day 0), and Post Treatment visit (3 weeks \[+/-3 days\] after last dose), a blood sample was collected prior to the start of infusion of study treatment. |
| Secondary | Percentage Change From Baseline in Total Kidney Volume (TKV) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. | After 3 weeks of treatment and 3 weeks post treatment | TKV was measured using magnetic resonance imaging. |
| Secondary | Mean Change From Baseline in 24 Hour Urine Volume After 3 Weeks Tolvaptan Treatment and at 3 Weeks Post Treatment. | 24 hours | A 24-hour split urine sample (approximate times: 0700 to 1700 hours, 1700 hours to bedtime, and bedtime to 0700 hours) was collected beginning the day before the Baseline, Final Treatment, and Post Treatment visits and ending at admission to the renal function ward. Individual voids in a collection interval were pooled and the total volume determined. |
| Secondary | Mean Change From Baseline in 2 Hour Urine Volume After 3 Weeks Tolvaptan Treatment and at 3 Weeks Post Treatment. | 2 hours | The volume of urine from each 2-hour urine collection in the renal function tests at Baseline, Final Treatment, and Post Treatment was recorded. Individual voids in a collection interval were pooled before determination of total volume. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Measured Glomerular Filtration Rate (mGFR) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. | After 3 weeks of treatment and 3 weeks post treatment | All participants who took any trial medication and had a postbaseline renal function test. | mL/min | MEAN |
| PRIMARY | Mean Change From Baseline in Effective Renal Plasma Flow (ERPF) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. | After 3 weeks of treatment and 3 weeks post treatment | All participants who took any trial medication and had a postbaseline renal function test. | mL/min | MEAN |
| PRIMARY | Mean Change From Baseline in Filtration Fraction (GFR/ERFP) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. | After 3 weeks of treatment and 3 weeks post treatment | All participants who took any trial medication and had a postbaseline renal function test. | Ratios | MEAN |
| SECONDARY | Mean Change From Baseline in Free Water Clearance After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment | After 3 weeks of treatment and 3 weeks post treatment | All participants who took any trial medication and had a postbaseline renal function test. | mL/min | MEAN |
| SECONDARY | Time to Peak Plasma Concentration (Cmax) After 3 Weeks of Tolvaptan Treatment. | Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hour | All participants who took any trial medication and had a postbaseline renal function test. | ng/mL | MEAN |
| SECONDARY | Time to Peak Plasma Concentration (Tmax) After 3 Weeks of Tolvaptan Treatment. | Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hour | All participants who took any trial medication and had a postbaseline renal function test. | hours | MEDIAN |
| SECONDARY | Area Under the Concentration-time Curve From 0 to 5 Hours (AUC0-5) After 3 Weeks of Tolvaptan Treatment. | Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hour | All participants who took any trial medication and had a postbaseline renal function test. | ng.h/mL | MEAN |
| SECONDARY | Percentage Change From Baseline in Total Kidney Volume (TKV) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. | After 3 weeks of treatment and 3 weeks post treatment | All participants who took any trial medication and had a postbaseline renal function test. | Percent | MEAN |
| SECONDARY | Mean Change From Baseline in 24 Hour Urine Volume After 3 Weeks Tolvaptan Treatment and at 3 Weeks Post Treatment. | 24 hours | All participants who took any trial medication and had a postbaseline renal function test. | mL | MEAN |
| SECONDARY | Mean Change From Baseline in 2 Hour Urine Volume After 3 Weeks Tolvaptan Treatment and at 3 Weeks Post Treatment. | 2 hours | All participants who took any trial medication and had a postbaseline renal function test. | mL | MEAN |
Source ClinicalTrials.gov
Results by group51
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Measured Glomerular Filtration Rate (mGFR) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. | eGFR > 60 mL/Min/1.73m2 | Final treatment change from Baseline | -8.0 | Standard Deviation 9.1 | mL/min |
| Mean Change From Baseline in Measured Glomerular Filtration Rate (mGFR) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. | eGFR 30-60 mL/Min/1.73m2 | Final treatment change from Baseline | -6.2 | Standard Deviation 6.2 | mL/min |
| Mean Change From Baseline in Measured Glomerular Filtration Rate (mGFR) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. | eGFR <30 mL/Min/1.73m2 | Final treatment change from Baseline | -0.7 | Standard Deviation 1.5 | mL/min |
| Mean Change From Baseline in Measured Glomerular Filtration Rate (mGFR) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. | eGFR > 60 mL/Min/1.73m2 | Post treatment change from Baseline | 0.1 | Standard Deviation 4.9 | mL/min |
| Mean Change From Baseline in Measured Glomerular Filtration Rate (mGFR) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. | eGFR 30-60 mL/Min/1.73m2 | Post treatment change from Baseline | -1.5 | Standard Deviation 4.0 | mL/min |
| Mean Change From Baseline in Measured Glomerular Filtration Rate (mGFR) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. | eGFR <30 mL/Min/1.73m2 | Post treatment change from Baseline | -1.2 | Standard Deviation 3.0 | mL/min |
| Mean Change From Baseline in Effective Renal Plasma Flow (ERPF) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. | eGFR > 60 mL/Min/1.73m2 | Final treatment change from Baseline | -16.9 | Standard Deviation 36.4 | mL/min |
| Mean Change From Baseline in Effective Renal Plasma Flow (ERPF) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. | eGFR 30-60 mL/Min/1.73m2 | Final treatment change from Baseline | -11.1 | Standard Deviation 18.4 | mL/min |
| Mean Change From Baseline in Effective Renal Plasma Flow (ERPF) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. | eGFR <30 mL/Min/1.73m2 | Final treatment change from Baseline | -1.7 | Standard Deviation 5.1 | mL/min |
| Mean Change From Baseline in Effective Renal Plasma Flow (ERPF) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. | eGFR > 60 mL/Min/1.73m2 | Post treatment change from Baseline | 4.3 | Standard Deviation 30.2 | mL/min |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | eGFR > 60 mL/Min/1.73m2 | 10 | |
| Overall Study | STARTED | eGFR 30-60 mL/Min/1.73m2 | 10 | |
| Overall Study | STARTED | eGFR <30 ml/Min/1.73m2 | 9 | |
| Overall Study | COMPLETED | eGFR > 60 mL/Min/1.73m2 | 9 | |
| Overall Study | COMPLETED | eGFR 30-60 mL/Min/1.73m2 | 9 | |
| Overall Study | COMPLETED | eGFR <30 ml/Min/1.73m2 | 9 | |
| Overall Study | NOT COMPLETED | eGFR > 60 mL/Min/1.73m2 | 1 | |
| Overall Study | NOT COMPLETED | eGFR 30-60 mL/Min/1.73m2 | 1 | |
| Overall Study | NOT COMPLETED | eGFR <30 ml/Min/1.73m2 | 0 |
Source ClinicalTrials.gov
Adverse events156
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 | eGFR > 60 mL/Min/1.73m2 | 1 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | eGFR 30-60 mL/Min/1.73m2 | 0 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | eGFR <30 mL/Min/1.73m2 | 1 | 9 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | eGFR > 60 mL/Min/1.73m2 | 0 | 10 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | eGFR 30-60 mL/Min/1.73m2 | 1 | 10 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | eGFR <30 mL/Min/1.73m2 | 0 | 9 | |
| other | Angina pectoris | Cardiac disorders | eGFR > 60 mL/Min/1.73m2 | 0 | 10 | |
| other | Angina pectoris | Cardiac disorders | eGFR 30-60 mL/Min/1.73m2 | 0 | 10 | |
| other | Angina pectoris | Cardiac disorders | eGFR <30 mL/Min/1.73m2 | 1 | 9 | |
| other | Bradycardia | Cardiac disorders | eGFR > 60 mL/Min/1.73m2 | 0 | 10 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | eGFR > 60 mL/Min/1.73m2 | ||
| Total, all-cause mortality | eGFR 30-60 mL/Min/1.73m2 | ||
| Total, all-cause mortality | eGFR <30 mL/Min/1.73m2 | ||
| Total, other adverse events | eGFR > 60 mL/Min/1.73m2 | 10 | 10 |
| Total, other adverse events | eGFR 30-60 mL/Min/1.73m2 | 10 | 10 |
| Total, other adverse events | eGFR <30 mL/Min/1.73m2 | 9 | 9 |
| Total, serious adverse events | eGFR > 60 mL/Min/1.73m2 | 1 | 10 |
| Total, serious adverse events | eGFR 30-60 mL/Min/1.73m2 | 0 | 10 |
| Total, serious adverse events | eGFR <30 mL/Min/1.73m2 | 1 | 9 |
Source ClinicalTrials.gov
Papers5
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.
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