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Can a diabetes drug protect kidneys in polycystic disease? new trial aims to find out

NCT ID NCT07280585

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether the drug dapagliflozin can slow the loss of kidney function in adults with autosomal dominant polycystic kidney disease (ADPKD), a common genetic cause of kidney failure. The study will enroll 420 people aged 18 to 60 with rapid disease progression. Participants will take either 10 mg of dapagliflozin or a placebo daily for 36 months, and researchers will measure changes in kidney function over time.

What this could mean

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

Active substance
Dapagliflozin (a drug that helps the kidneys remove sugar from the blood, also used for diabetes and heart failure)
What this could lead to
If it works, this could provide a new treatment option to slow kidney decline in people with polycystic kidney disease, potentially delaying the need for dialysis or transplant.
What could go wrong
This is a phase 3 trial, but the drug is already approved for other conditions. It may not slow kidney function loss in this specific disease, and side effects like urinary tract infections or dehydration are possible.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 420 people

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

Started

Dec 2025

Expected to finish

May 2030

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.

Ages

18 to 60 years

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: * Male and female patients with ADPKD (modified Ravine criteria) ≥ 18 and ≤ 60 years * Patients 18 - 39 years: eGFR ≥25 ml/min; patients 40 - 60 years: eGFR ≥25 and \<90 ml/min/1.73 m2 * Indicators of rapid progression, either of the following: * Mayo class 1D-E * Mayo class 1C AND EITHER 1. Truncating PKD1 mutation OR 2. eGFR loss \> 3ml/min/year (determined by ≥ 4 creatinine values within 4 years, ≥ 6 months measurement intervals) OR 3. PROPKD score \> 6 (patient history) * IF patient is on ACE-I /ARBs: stable dose for 4 weeks before screening Exclusion Criteria: * Treatment with tolvaptan, somatostatin analogue, lithium or SGLT2i within the last 3 months before screening * Medical history of diabetic ketoacidosis, necrotizing fasciitis or organ transplantation * Diabetes mellitus type 1 or any type of diabetes mellitus due to insulin deficiency * Uncontrolled ongoing urinary tract or genital infections * Known intolerance of the study medication ingredients * Uncontrolled grade 2 hypertension (\>160/100 mmHg) * Symptomatic hypotension, or systolic blood pressure \<90 mmHg * Primary renal disease other than ADPKD * Hepatic impairment (aspartate transaminase \[AST\] or alanine transaminase \[ALT\]\>3x the up-per limit of normal \[ULN\]; or total bilirubin \>2x ULN at time of enrolment) * Pregnancy, breastfeeding or women of child-bearing potential not using effective contraception method * Not able to comply with the study protocol, in the investigator's judgement * Not able to provide informed consent * Participation in any other interventional clinical trial in the last 2 months

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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.

Polycystic kidney, autosomal dominant

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    30 sites in 4 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Charite Universitaetsmedizin Berlin KöR

    RECRUITING

    Berlin, Germany

  • Erasmus Universitair Medisch Centrum Rotterdam

    RECRUITING

    Rotterdam, Netherlands

  • Fundacio Hospital Universitari Vall D'Hebron Institut De Recerca

    NOT_YET_RECRUITING

    Barcelona, Spain

  • Fundacio Puigvert

    NOT_YET_RECRUITING

    Barcelona, Spain

  • Goethe University Frankfurt

    RECRUITING

    Frankfurt, Germany

  • Klinikum Der Landeshauptstadt Stuttgart gKAöR

    RECRUITING

    Stuttgart, Germany

  • Klinikum Dortmund gGmbH

    RECRUITING

    Dortmund, Germany

  • Klinikum Nürnberg

    NOT_YET_RECRUITING

    Nuremberg, Bavaria, 90471, Germany

  • Klinikum der Technischen Universitaet Muenchen

    RECRUITING

    München, Germany

  • LMU Klinikum Muenchen AöR

    RECRUITING

    München, Germany

  • Leids Universitair Medisch Centrum

    NOT_YET_RECRUITING

    Leiden, Netherlands

  • Medical Center - University of Freiburg

    NOT_YET_RECRUITING

    Freiburg im Breisgau, 79106, Germany

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, Germany

  • Medizinische Universitaet Innsbruck

    RECRUITING

    Innsbruck, Austria

  • Robert Bosch Gesellschaft für Medizinische Forschung mbH

    RECRUITING

    Stuttgart, Baden-Wurttemberg, 70376, Germany

  • Universitaet Leipzig

    RECRUITING

    Leipzig, Germany

  • Universitaetsklinikum Aachen AöR

    RECRUITING

    Aachen, Germany

  • Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR

    RECRUITING

    Dresden, Germany

  • Universitaetsklinikum Duesseldorf AöR

    RECRUITING

    Düsseldorf, Germany

  • Universitaetsklinikum Heidelberg AöR

    RECRUITING

    Heidelberg, Germany

  • Universitaetsklinikum Jena KöR

    RECRUITING

    Jena, Germany

  • Universitaetsklinikum Schleswig-Holstein AöR

    RECRUITING

    Kiel, Germany

  • Universitaetsklinikum Schleswig-Holstein AöR

    RECRUITING

    Lübeck, Germany

  • Universitaetsmedizin Goettingen

    RECRUITING

    Göttingen, Germany

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

    RECRUITING

    Mainz, Germany

  • Universitair Medisch Centrum Groningen

    RECRUITING

    Groningen, Netherlands

    Contact Email: •••••@•••••

  • University Medical Center Hamburg-Eppendorf

    RECRUITING

    Hamburg, Germany

  • Universitätsklinikum Köln

    RECRUITING

    Cologne, Germany

  • Vorarlberger Krankenhaus-Betriebsgesellschaft

    RECRUITING

    Feldkirch, Austria

  • Zentrum Fuer Nieren Hochdruck Und Stoffwechselerkrankungen

    NOT_YET_RECRUITING

    Hanover, Germany

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