RecruitingPHASE3INTERVENTIONAL

STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease

This study, called STOP-PKD, is looking into whether a medication called dapagliflozin can help people with a common genetic kidney condition known as Autosomal Dominant Polycystic Kidney Disease (ADPKD). ADPKD causes fluid-filled cysts to grow in the kidneys, leading to them not working as well over time. The study wants to see if dapagliflozin can slow down this loss of kidney function. Currently, there aren't many widely used treatments for ADPKD. This trial is comparing dapagliflozin to a 'dummy' pill (placebo) to find out if it's safe and effective. It's a large study, involving patients aged 18 to 60, and aims to provide clear answers about this potential new treatment.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University of Cologne

Enrolment target

420

Start

16 Dec 2025

Estimated completion

15 May 2030

Polycystic Kidney, Autosomal Dominant

What is this study about?

Autosomal Dominant Polycystic Kidney Disease, or ADPKD, is a genetic condition that causes many fluid-filled sacs, called cysts, to grow in your kidneys. Over time, these cysts can get bigger and more numerous, leading to the kidneys not working as well as they should. This can eventually lead to kidney failure, which is when the kidneys stop working completely and treatment like dialysis or a kidney transplant is needed. ADPKD is the most common genetic cause of kidney failure.

At the moment, there's only one approved treatment that can help slow down the disease, and it's not suitable for everyone. This means doctors are always looking for new and better ways to help people with ADPKD. Recently, a type of drug called SGLT2 inhibitors has been shown to help protect kidneys in people with other kidney conditions. However, people with ADPKD weren't included in those original studies, so we don't yet know if these drugs are helpful for them.

This study, called STOP-PKD, aims to find out if one of these SGLT2 inhibitor drugs, called dapagliflozin, can slow down the worsening of kidney function in people with ADPKD. Participants will either receive dapagliflozin or a matching dummy pill (placebo) for a period of time. Researchers will carefully check how their kidneys are working to see if the drug makes a difference. This research is really important because it could lead to another helpful treatment option for people living with ADPKD.

Key takeaways

This study investigates if dapagliflozin can slow down kidney damage in ADPKD.
It uses a 'dummy' pill (placebo) to accurately compare effects.
Participation involves regular clinic visits for tests and health checks.
People aged 18-60 with a specific range of kidney function may be eligible.
This research could offer a new treatment option for ADPKD.
You can stop participating at any time without affecting your usual care.

Who may be eligible?

To join this study, you generally need to be an adult with ADPKD, aged between 18 and 60 years old. Your kidney function also needs to be within a specific range, showing that your kidneys are still working to some extent but also that your condition might be getting worse over time.

The research team will also look for signs that your ADPKD is likely to progress more quickly. This could be based on your specific genetic information, how quickly your kidney function has changed in the past, or how your cysts look on imaging scans.

There are also some reasons why you couldn't join. For example, if you're already taking certain other medications for ADPKD or have other serious health conditions like specific types of diabetes, uncontrolled high blood pressure, or a history of certain severe infections. Women who are pregnant, breastfeeding, or could become pregnant and are not using effective contraception also cannot participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 60 years old?
Do you have a diagnosis of ADPKD?
Are your kidneys still working, but perhaps showing signs of getting worse?
Are you able to take a daily pill?
Are you not currently taking other specific ADPKD medications (like tolvaptan)?
Are you not pregnant, breastfeeding, or planning to become pregnant without using effective contraception?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to either receive the study drug, dapagliflozin, or a matching dummy pill (placebo). This means neither you nor your study doctor will know which one you are taking until the end of the study. You'll take your study medication once a day.

Throughout the study, you'll have regular visits to the clinic. These visits will involve various assessments, such as blood and urine tests to check your kidney function, blood pressure measurements, and possibly imaging scans to look at your kidneys. These tests help the researchers understand how the medication is affecting your body. The study will last for a period of time, and you'll have follow-up visits to monitor your health. The medical team will explain the exact schedule of visits and tests during the consent process.

Potential risks and benefits

Participating in a clinical trial can have potential benefits, such as gaining access to a new treatment before it's widely available and receiving close medical monitoring, which might otherwise not be part of your routine care. However, there are also potential risks; you might experience side effects from the study drug, or the treatment may not work for you. Since some participants will receive a placebo, they won't be receiving the active drug. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (27)

Vorarlberger Krankenhaus-Betriebsgesellschaft
Verified postcode
Feldkirch, Austria· Not yet recruiting
Medizinische Universitaet Innsbruck
Verified postcode
Innsbruck, Austria· Not yet recruiting
Universitaetsklinikum Aachen AöR
Verified postcode
Aachen, Germany· Recruiting
Charite Universitaetsmedizin Berlin KöR
Verified postcode
Berlin, Germany· Recruiting
Universitätsklinikum Köln
Verified postcode
Cologne, Germany· Recruiting
Klinikum Dortmund gGmbH
Verified postcode
Dortmund, Germany· Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Verified postcode
Dresden, Germany· Recruiting
Universitaetsklinikum Duesseldorf AöR
Verified postcode
Düsseldorf, Germany· Not yet recruiting
Goethe University Frankfurt
Verified postcode
Frankfurt, Germany· Recruiting
Universitaetsmedizin Goettingen
Verified postcode
Göttingen, Germany· Not yet recruiting
University Medical Center Hamburg-Eppendorf
Verified postcode
Hamburg, Germany· Not yet recruiting
Medizinische Hochschule Hannover
Verified postcode
Hanover, Germany· Recruiting

Common questions

What is ADPKD?

ADPKD is a genetic condition where fluid-filled sacs, called cysts, grow in your kidneys, which can cause them to lose their function over time.

What is dapagliflozin?

Dapagliflozin is a drug that helps your kidneys remove sugar from your body. It has been shown to protect kidneys in people with other conditions, and this study wants to see if it helps with ADPKD.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the study drug but contains no active medicine. It helps researchers check if the study drug is truly effective.

Will I know if I'm getting the real drug or the dummy pill?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you are receiving dapagliflozin or the placebo until the study is over.

How long will the study last?

The study's full duration will be explained by the research team if you are eligible and interested in participating.

How to find out more

Roman-Ulrich Müller, Prof.

stop-pkd@uk-koeln.de +49221478191005 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.