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Kidney drug tolvaptan put to the test in Real-World japanese patients

NCT ID NCT02847624

Disease control Sponsor: Otsuka Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 1802 Japanese patients with autosomal dominant polycystic kidney disease (ADPKD) who were taking tolvaptan in real-world clinics. Researchers tracked safety and how well the drug slowed kidney growth. The goal was to see if tolvaptan works as well outside controlled trials as it does in them.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tolvaptan
What this could lead to
If successful, this study could confirm that tolvaptan safely slows kidney growth in ADPKD patients in everyday clinical practice.
What could go wrong
This is an observational follow-up study, not a new treatment test. Results may not apply outside Japan, and tolvaptan can cause liver side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,802 people

The number who actually took part.

Started

Mar 2014

Finished

Sep 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

medical institutes all over Japan

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * diagnosed ADPKD * total kidney volume of 750 or more Exclusion Criteria: \-

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Conditions

The condition(s) this trial relates to.

autosomal dominant polycystic kidney disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Polycystic kidney, autosomal dominant

Contacts and locations

Locations

  • Otsuka Pharmaceutical Co., Ltd.

    Tokyo, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.