Trial · NCT01451827

8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

NCT01451827, Phase 2, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2018-08-13

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. 8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD). Trials, record NCT01451827. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01451827

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
NCT number: NCT01451827
Status: Completed
Phases: Phase 2
Enrollment: 178 participants, actual
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions: Autosomal Dominant Polycystic Kidney Disease
Interventions: Tolvaptan MR, Tolvaptan IR, Placebo
First posted: 2011-10-14
Last updated: 2018-09-27
Results first posted: 2018-08-13

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline in Total Kidney Volume (TKV) at Week 3	Baseline to Week 3	The primary endpoint was percent change from baseline in TKV at Week 3. Total kidney volume is an important measure of disease progression. A 3-week time point is adequate to assess acute effects on kidney cyst shrinkage.
Secondary	Change From Baseline in Total Score of the Autosomal Dominant Polycystic Kidney Disease Urinary Impact Scale (ADPKD-UIS)	Baseline to Week 8	The ADPKD-UIS was a self-administered questionnaire designed to measure ADPKD-related urinary symptoms in participants with ADPKD. This instrument contained 11 items in 3 domains (Urinary Frequency, Urinary Urgency, and Nocturia). Each item was scored using a scale of 1 to 5 (a higher score indicated increased difficulty/extremely bothered). The maximum total score is 55; 1: not difficult/not bothered at all; 55: extremely difficult/extremely bothered.
Secondary	Percent Change From Baseline in TKV at Week 8.	Baseline to Week 8	Total kidney volume is an important measure of disease progression. A 3-week time point is adequate to assess acute effects on kidney cyst shrinkage.

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	Percent Change From Baseline in Total Kidney Volume (TKV) at Week 3	Baseline to Week 3	Participants who were randomized and had baseline and post-baseline observations in the total renal volume.	Percentage change	MEAN
SECONDARY	Change From Baseline in Total Score of the Autosomal Dominant Polycystic Kidney Disease Urinary Impact Scale (ADPKD-UIS)	Baseline to Week 8	Participants who were randomized and had baseline and post-baseline observations in the total renal volume.	Unit on a scale	MEAN
SECONDARY	Percent Change From Baseline in TKV at Week 8.	Baseline to Week 8	The core patient population for all efficacy analyses was based on the intent-to-treat (ITT) population which consisted of all randomized participants who take at least one dose of study drug. Observed Cases (OC) dataset within treatment period was defined as the data observed at study specified visits while subjects are taking study drug.	Percentage change	MEAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percent Change From Baseline in Total Kidney Volume (TKV) at Week 3	Tolvaptan MR 50 mg		-2.46	Standard Deviation 4.40	Percentage change
Percent Change From Baseline in Total Kidney Volume (TKV) at Week 3	Tolvaptan MR 80 mg		-2.55	Standard Deviation 3.85	Percentage change
Percent Change From Baseline in Total Kidney Volume (TKV) at Week 3	Tolvaptan IR 60/30 mg		-1.17	Standard Deviation 4.52	Percentage change
Percent Change From Baseline in Total Kidney Volume (TKV) at Week 3	Placebo		0.09	Standard Deviation 5.31	Percentage change
Change From Baseline in Total Score of the Autosomal Dominant Polycystic Kidney Disease Urinary Impact Scale (ADPKD-UIS)	Tolvaptan MR 50 mg	Urinary Frequency	0.74	Standard Deviation 0.94	Unit on a scale
Change From Baseline in Total Score of the Autosomal Dominant Polycystic Kidney Disease Urinary Impact Scale (ADPKD-UIS)	Tolvaptan MR 80 mg	Urinary Frequency	0.82	Standard Deviation 0.83	Unit on a scale
Change From Baseline in Total Score of the Autosomal Dominant Polycystic Kidney Disease Urinary Impact Scale (ADPKD-UIS)	Tolvaptan IR 60/30 mg	Urinary Frequency	0.99	Standard Deviation 0.78	Unit on a scale
Change From Baseline in Total Score of the Autosomal Dominant Polycystic Kidney Disease Urinary Impact Scale (ADPKD-UIS)	Placebo	Urinary Frequency	0.10	Standard Deviation 0.35	Unit on a scale
Change From Baseline in Total Score of the Autosomal Dominant Polycystic Kidney Disease Urinary Impact Scale (ADPKD-UIS)	Tolvaptan MR 50 mg	Urinary Urgency	0.69	Standard Deviation 0.96	Unit on a scale
Change From Baseline in Total Score of the Autosomal Dominant Polycystic Kidney Disease Urinary Impact Scale (ADPKD-UIS)	Tolvaptan MR 80 mg	Urinary Urgency	0.66	Standard Deviation 0.77	Unit on a scale

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tolvaptan Modifed Release (MR) 50 mg	45
Overall Study	STARTED	Tolvaptan MR 80 mg	45
Overall Study	STARTED	Tolvaptan Immediate Release (IR) 60/30 mg	44
Overall Study	STARTED	Placebo	43
Overall Study	COMPLETED	Tolvaptan Modifed Release (MR) 50 mg	42
Overall Study	COMPLETED	Tolvaptan MR 80 mg	40
Overall Study	COMPLETED	Tolvaptan Immediate Release (IR) 60/30 mg	42
Overall Study	COMPLETED	Placebo	39
Overall Study	NOT COMPLETED	Tolvaptan Modifed Release (MR) 50 mg	3
Overall Study	NOT COMPLETED	Tolvaptan MR 80 mg	5

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events76

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
other	Dry mouth	Gastrointestinal disorders	Tolvaptan MR 50 mg	7	45
other	Dry mouth	Gastrointestinal disorders	Tolvaptan MR 80 mg	7	44
other	Dry mouth	Gastrointestinal disorders	Tolvaptan IR 60/30 mg	2	44
other	Dry mouth	Gastrointestinal disorders	Placebo	1	42
other	Nausea	Gastrointestinal disorders	Tolvaptan MR 50 mg	2	45
other	Nausea	Gastrointestinal disorders	Tolvaptan MR 80 mg	1	44
other	Nausea	Gastrointestinal disorders	Tolvaptan IR 60/30 mg	2	44
other	Nausea	Gastrointestinal disorders	Placebo	4	42
other	Fatigue	General disorders	Tolvaptan MR 50 mg	3	45
other	Fatigue	General disorders	Tolvaptan MR 80 mg	2	44

1 to 10 of 76Source ClinicalTrials.gov

See all 76 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tolvaptan MR 50 mg	0	45
Total, all-cause mortality	Tolvaptan MR 80 mg	0	44
Total, all-cause mortality	Tolvaptan IR 60/30 mg	0	44
Total, all-cause mortality	Placebo	0	42
Total, other adverse events	Tolvaptan MR 50 mg	27	45
Total, other adverse events	Tolvaptan MR 80 mg	25	44
Total, other adverse events	Tolvaptan IR 60/30 mg	32	44
Total, other adverse events	Placebo	18	42
Total, serious adverse events	Tolvaptan MR 50 mg	3	45
Total, serious adverse events	Tolvaptan MR 80 mg	1	44

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39356039	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01451827

GET https://conductscience.org/api/trials/v1/NCT01451827/events?page=2

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