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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 4

    End of treatment

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

  5. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

3 criteria

  • 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
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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.

What is already known about the treatment

Dapagliflozin – Dapagliflozin is a medication taken by mouth in tablet form that belongs to a class of drugs called SGLT2 inhibitors, which work by helping the kidneys remove excess sugar from the blood through urine. This medication is approved for treating type 2 diabetes, heart failure, and chronic kidney disease, and is now being studied in clinical trials to see if it can slow down the loss of kidney function in patients with autosomal dominant polycystic kidney disease (ADPKD), a genetic condition where fluid-filled cysts grow in the kidneys. At the molecular level, it blocks a protein called sodium-glucose co-transporter 2 in the kidney tubes, preventing sugar from being reabsorbed back into the blood and instead allowing it to be eliminated in urine. By reducing the workload on the kidneys and potentially decreasing cyst growth, researchers hope this drug may help preserve kidney function longer in ADPKD patients.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521276-59-00Protocol codeUni-Koeln-5522Estimated enrolment420 patientsSponsorUniversity Of Cologne

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