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Effect of dapagliflozin on cardiovascular events in patients receiving chronic dialysis

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What is this trial about?

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

The study focuses on people who are receiving Chronic dialysis and who also have Cardiovascular disease. Participants will be given the oral medication DAPAGLIFLOZIN, which belongs to the class of drugs known as SGLT2i. This medication is added to the usual treatments that patients already receive for their kidney and heart conditions.

The main goal is to see whether adding the study drug lowers the chance of a combined outcome called MACE, which includes death from heart problems, hospital visits for HF, a heart attack (myocardial infarction), or a stroke caused by blocked arteries (ischemic stroke). After enrollment, participants will take the study medication daily while continuing their regular care. They will attend regular check‑ins where doctors will record any heart‑related events, hospital stays, and overall health status. Simple questionnaires such as the KCCQ-12 will be used to assess symptoms, and patients will report how quickly they feel recovered after each hemodialysis session. The study follows participants over time to compare outcomes between those receiving the added drug and those who receive standard care alone.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial study visit

    You will meet the study staff for a baseline assessment. this includes recording your medical history, confirming that you are on chronic dialysis, and checking for any cardiovascular disease.

    The staff will explain the study procedures and answer any questions you have.

  2. Step 2

    Receive study medication instructions

    You will be given a prescription for dapagliflozin. the medication comes in a tablet form that is taken by mouth.

    The prescribed dose is 10 mg and it should be taken once daily.

  3. Step 3

    Start taking dapagliflozin

    You will begin taking the tablet each day as instructed, continuing your usual dialysis schedule.

    The medication is taken in addition to the standard care you already receive for dialysis and any other heart‑related treatments.

  4. Step 4

    Continue standard dialysis care

    Your regular dialysis sessions will continue without change unless your doctor advises otherwise.

    The study does not replace any of your current treatments.

  5. Step 5

    Regular follow‑up visits

    You will attend scheduled visits at the clinic. during each visit the staff will check your health, review any side effects, and record any events such as hospitalizations or heart problems.

    The frequency of these visits will be determined by the study schedule and will be explained to you at the start.

  6. Step 6

    Report health events

    If you experience a hospitalization, heart failure, heart attack, stroke, or any other serious health problem, you must inform the study staff as soon as possible.

    These events are part of the study’s outcome measurements, known as major adverse cardiovascular events (MACE).

  7. Step 7

    Continue medication for the study period

    You will keep taking dapagliflozin 10 mg daily for as long as you remain in the trial.

    The study may last several years, ending when the overall trial is completed or if you choose to stop participating.

  8. Step 8

    Final study visit

    At the end of your participation you will have a final visit. the staff will perform a last health assessment and collect any remaining study data.

    After this visit you will no longer receive the study medication, but you will continue any regular treatments prescribed by your healthcare provider.

Who can join the trial?

4 criteria

  • Signed written informed consent – you must read and sign a document (paper or electronic) that explains the study and confirms you agree to take part.
  • Age 18 years or older – you must be an adult (18 years old or more).
  • Receiving chronic dialysis for at least three months – you must have been on regular dialysis (a treatment that cleans the blood when the kidneys cannot) continuously for three months or more.
  • If you are a woman who could become pregnant, you must have a negative pregnancy test (called an S‑HCG test) and agree to use birth control methods as instructed for the whole time you take the study medication.

Who cannot join the trial?

8 criteria

  • Having type 1 diabetes (a condition where the body cannot produce insulin).
  • Having severe liver failure (the liver is badly damaged; a score called Child‑Pugh of 10 or higher, or an advanced cirrhosis that is no longer working).
  • Being unable to tolerate the study drug SGLT2i (a type of medicine that helps the kidneys remove sugar).
  • Currently taking lithium (a medication often used for mood disorders).
  • Being pregnant or breastfeeding (carrying a baby or feeding a baby with breast milk).
  • Any other illness or situation that the doctor thinks makes participation unsafe.
  • Being scheduled to receive a kidney from a living donor transplantation (a transplant from a living person).
  • Having a good chance of getting kidney function back and possibly stopping dialysis (the treatment that cleans the blood when kidneys fail).
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Investigated drugs

dapagliflozin is a medicine that belongs to a class called SGLT2 inhibitors. It works by helping the kidneys remove extra sugar from the blood through the urine. In this trial, the drug is being tested to see if adding it to the usual treatment for people who are on long‑term dialysis can lower the chance of serious heart problems such as heart attacks or strokes.

The trial also includes the standard of care for patients on chronic dialysis. This refers to the regular treatments and medical management that dialysis patients normally receive, such as regular dialysis sessions, blood pressure control, and other medications prescribed for their kidney disease and overall health. The study compares patients who receive dapagliflozin on top of this usual care with those who continue with the usual care alone.

What is already known about the treatment

Dapagliflozin - Dapagliflozin is taken by mouth as a tablet, typically 10 mg once daily. It is an approved medicine for type 2 diabetes and is also recognized in guidelines for heart failure and chronic kidney disease, with extensive study in medical literature. It is used mainly to lower blood sugar and to protect the heart and kidneys in patients with diabetes or kidney problems. The drug works by blocking the SGLT2 protein in the kidney, which stops glucose from being re‑absorbed and causes excess sugar to leave the body in urine; this classifies it as an SGLT2 inhibitor, a type of oral glucose‑lowering medication.

Investigated diseases

  • Chronic dialysis

    This condition occurs when the kidneys can no longer filter waste and excess fluid from the blood, so the patient requires regular dialysis sessions to perform this function. Over time the need for dialysis continues because kidney function does not recover, and the treatment schedule often becomes a permanent part of daily life. The body may experience gradual changes in fluid balance and electrolyte levels as the kidneys remain non‑functional.

  • Cardiovascular disease

    This term covers disorders that affect the heart and blood vessels, such as narrowing of arteries, heart muscle problems, and rhythm disturbances. The disease typically develops slowly as plaques build up in arteries, reducing blood flow. Reduced blood flow can lead to the heart working harder, which may cause the heart muscle to weaken or the rhythm to become irregular. The condition usually worsens over years as the vessels and heart are repeatedly stressed.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2026-526075-35-00Protocol code2026-526075-35-00Estimated enrolment1 000 patientsSponsorKarolinska University Hospital

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).