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Testing dapagliflozin to slow kidney function decline in patients with autosomal dominant polycystic kidney disease

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What is this study about?

This study is looking at autosomal dominant polycystic kidney disease, which is an inherited condition where multiple fluid-filled sacs called cysts develop in the kidneys over time. These cysts can cause the kidneys to grow larger and gradually lose their ability to work properly. The study will use a medication called dapagliflozin, which is a medicine that helps the kidneys remove extra sugar from the body through urine. Some participants will receive dapagliflozin while others will receive placebo. The purpose of the study is to find out whether dapagliflozin can slow down the decline in kidney function in people with this disease.

Participants in this study will take the study medication for about three years. During this time, they will have regular visits where blood tests will be done to measure how well their kidneys are working. These measurements will help researchers understand if the medication is helping to slow down the loss of kidney function. Some participants will also have imaging scans to measure the size of their kidneys after one year of treatment. The study is designed for adults between 18 and 60 years of age who have signs that their kidney disease is getting worse more quickly than usual.

Throughout the study, doctors will monitor participants for any unwanted effects of the medication and will check how the kidneys are responding to treatment. After completing the treatment period, participants will have follow-up visits where additional measurements will be taken to see what happens after stopping the medication. The study will collect information about serious health problems and specific side effects that may be related to the treatment. All of this information will help researchers understand whether this medication could be a useful treatment option for people living with polycystic kidney disease.

1 Treatment initiation and stabilization period

At the start of the study, you will begin taking the assigned study medication. This will be either dapagliflozin 10 mg or a placebo (an inactive tablet that looks identical to the real medication). The medication is provided as a film-coated tablet that you will take by mouth.

The first 6 weeks serve as a stabilization period. During this time, your body adjusts to the study medication.

2 Main treatment phase

After the initial 6 weeks, you will continue taking your assigned study medication daily. This main treatment phase lasts until week 156 (approximately 3 years).

Throughout this period, you will attend regular study visits where blood samples will be collected to measure your creatinine levels. Creatinine is a waste product in your blood that helps doctors assess how well your kidneys are functioning. These measurements are used to calculate your eGFR (estimated glomerular filtration rate), which indicates how efficiently your kidneys are filtering blood.

All creatinine measurements taken from week 6 to week 156 will be used to evaluate the primary outcome of the study, which is the rate of decline in your kidney function over time.

3 Kidney imaging assessment

If you are among the first 150 patients enrolled in the study, you will undergo additional imaging to measure your total kidney volume.

This imaging will be performed at the beginning of the study (baseline) and again at week 48 (after approximately 1 year). The purpose is to assess whether the study medication affects the size of your kidneys.

4 End of treatment

At week 156, you will stop taking the study medication. This marks the end of the treatment phase.

5 Follow-up period

After stopping the study medication, you will enter a follow-up phase lasting 12 weeks.

During this time, blood samples will be collected at week 162 and week 168 to measure your creatinine levels. These measurements allow doctors to assess your kidney function after treatment has ended.

The follow-up phase concludes at week 168, which is the final study visit.

6 Safety monitoring throughout the study

Throughout the entire study, any adverse events (unwanted or harmful effects) and serious adverse events (severe medical problems) will be recorded and monitored.

Particular attention will be paid to specific adverse events of interest related to the study medication.

Who Can Join the Study?

  • You must be 18 to 60 years old, either male or female
  • You must have autosomal dominant polycystic kidney disease, which is an inherited condition where fluid-filled sacs called cysts grow in the kidneys
  • If you are between 18 and 39 years old, your eGFR (a blood test that measures how well your kidneys are filtering waste) must be at least 25
  • If you are between 40 and 60 years old, your eGFR must be at least 25 but less than 90
  • You must have signs that your kidney disease is getting worse quickly, shown by one of the following: you are classified as Mayo class 1D or 1E (a scoring system that predicts how fast your kidney disease will progress), or you are Mayo class 1C and also have one of these: a specific type of genetic change called a truncating PKD1 mutation, or your kidney function has decreased by more than 3 units per year based on at least 4 blood tests over 4 years with at least 6 months between tests, or you have a PROPKD score greater than 6 (another scoring system based on your medical history that predicts disease progression)
  • If you are taking medications called ACE inhibitors or ARBs (medicines used to lower blood pressure and protect the kidneys), you must have been on the same dose for at least 4 weeks before the screening visit

Who Cannot Join the Study?

  • The specific exclusion criteria (reasons why you cannot participate in this study) have not been provided in the available information
  • If you are interested in this study, the research team will need to review your complete medical history to determine if you meet all requirements for participation
  • Generally, clinical trials have specific rules about who can and cannot participate to ensure patient safety and accurate results

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Medizinische Hochschule Hannover Hanover Germany
University Hospital Jena KöR Jena Germany
Universitaetsmedizin Goettingen Goettingen Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Universitaet Leipzig Leipzig Germany
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Klinikum Dortmund gGmbH Dortmund Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Zentrum Fuer Nieren Hochdruck Und Stoffwechselerkrankungen Hanover Germany
Fundacio Puigvert Barcelona Spain
Klinikum Der Landeshauptstadt Stuttgart gKAöR Stuttgart Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH Feldkirch Austria
Klinikum Nuernberg Nürnberg Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Robert Bosch Gesellschaft fuer medizinische Forschung mbH Stuttgart Germany
Uudohmoniu Mimwijb Cdrjfh Hbpltiyogtzfodnns Hamburg Germany
Lgkib Uqdoxjdcptqa Mhlspvt Csclnlw (xnlfg Leiden The Netherlands
Uxwhaaltcmzj Mkldgcp Czrzwgi Gbullayqf Groningen The Netherlands
Udrtxpdbzu Hvpeullh Covpspd Cologne Germany
Uivmrgfhfbcjnyrlxzrkb Dqbutpgybed Any Duesseldorf Germany
Etoftia Ukfmkmgrcvqo Mqrovax Cxmaxnx Rtodzrdnp (pjrcnqa Mhi Rotterdam The Netherlands
Gjzshh Uzsemkynhu Fzjiodqpk Frankfurt Germany
Kbvulefb dxm Ufvrwlmkrthk Mmkudaps Afm Munich Germany
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
01.10.2025
Germany Germany
Recruiting
01.10.2025
Spain Spain
Not yet recruiting
01.10.2025
The Netherlands The Netherlands
Recruiting
01.10.2025

Trial locations

Investigated drugs:

Dapagliflozin is a medication that helps the kidneys remove sugar from the body through urine. It was originally developed to treat diabetes, but in this study it is being tested to see if it can slow down the loss of kidney function in people with a genetic condition called polycystic kidney disease. This medication works by blocking a specific protein in the kidneys, which changes how the kidneys filter blood and may help protect them from further damage.

Autosomal Dominant Polycystic Kidney Disease – This is an inherited disorder where numerous fluid-filled sacs called cysts develop primarily in the kidneys. The condition is passed from parent to child through genes, requiring only one copy of the abnormal gene to develop the disease. Over time, the cysts grow in number and size, gradually replacing normal kidney tissue. As the disease progresses, the kidneys become enlarged and lose their ability to filter waste products from the blood effectively. This leads to a gradual decline in kidney function over many years. The condition may also cause cysts in other organs such as the liver and pancreas.

Trial ID:
2025-521276-59-00
Protocol code:
Uni-Koeln-5522
Trial Phase:
Therapeutic confirmatory (Phase III)

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