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Kidney disease drug under the microscope: how does tolvaptan really work?

NCT ID NCT02497521

Knowledge-focused Sponsor: University of Cologne Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is tracking up to 2,000 people with autosomal dominant polycystic kidney disease (ADPKD) who are taking or considering tolvaptan. Researchers will collect real-world data on dosing, side effects, and kidney function over time. The goal is to understand how the drug is used in everyday practice and how well it works outside of controlled clinical trials.

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 registry will provide real-world evidence on how tolvaptan is best used to slow kidney disease in ADPKD patients.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by differences in patient care.

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

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2015

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Patients with diagnosis of ADPKD and therapy with tolvaptan

Ages

18 years and older

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: * Age \> 18 years * ADPKD proven by positive family history and evidence of renal cysts or diagnosed by treating physician * Presentation at our center for tolvaptan treatment indication, or tolvaptan treatment planned, or tolvaptan already started Exclusion Criteria: * Patients not capable of giving informed consent * End stage renal disease requiring renal replacement therapy * Patients receiving tolvaptan as "off-label use"

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Conditions

The condition(s) this trial relates to.

autosomal dominant polycystic kidney disease polycystic kidney disease

As listed by the trial registrant

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

Adpkd (autosomal dominant polycystic kidney disease)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Charité Universitätsmedizin Berlin

    ACTIVE_NOT_RECRUITING

    Berlin, State of Berlin, 10117, Germany

  • Fachinternistische Gemeinschaftspraxis Markgraeferland

    RECRUITING

    Müllheim, Baden-Wurttemberg, 79379, Germany

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, Lower Saxony, 30625, Germany

  • Nieren- und Diabeteszentrum Nettetal-Lobberich

    ACTIVE_NOT_RECRUITING

    Nettetal, North Rhine-Westphalia, 41334, Germany

  • Nierenzentrum Lübeck

    RECRUITING

    Lübeck, Schleswig-Holstein, 23562, Germany

  • Praxisgemeinschaft Dr. Peschel

    RECRUITING

    Leipzig, Saxony, 04107, Germany

  • Robert-Bosch-Krankenhaus

    RECRUITING

    Stuttgart, 70376, Germany

  • University Hospital of Cologne

    RECRUITING

    Cologne, North Rhine-Westphalia, 50937, Germany

  • University Hospital of Jena

    RECRUITING

    Jena, Thuringia, 07747, Germany

  • University Hospital of Leipzig, Nephrologische Ambulanz

    RECRUITING

    Leipzig, Saxony, 04103, Germany

  • University Hospital of Schleswig-Holstein

    RECRUITING

    Lübeck, Schleswig-Holstein, 23538, Germany

  • University Hospital of Wuerzburg, ZIM

    RECRUITING

    Würzburg, Bavaria, 97080, Germany

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