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Study on Dapagliflozin for Patients with Chronic Kidney Disease or Kidney Failure Undergoing Hemodialysis

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What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called dapagliflozin, which is marketed under the name Forxiga, in patients undergoing hemodialysis. Hemodialysis is a treatment for people with severe kidney problems, such as Chronic Kidney Disease and Kidney Failure. The study also looks at patients with a heart condition known as Left Ventricular Hypertrophy, which is a thickening of the heart's left pumping chamber. The purpose of the study is to compare the effects of dapagliflozin with a placebo on heart health in these patients.

Participants in the study will be randomly assigned to receive either dapagliflozin or a placebo. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased. The study will last for about six months, during which time the participants will continue their regular hemodialysis treatments while taking the study medication or placebo. The main focus will be on changes in the heart's structure and function, particularly the Left Ventricular Mass, which is a measure of the heart's size and health.

Throughout the study, various health markers will be monitored, including blood sugar levels, hormones, and heart function indicators. The goal is to see if dapagliflozin can improve heart health and overall quality of life for patients on hemodialysis. The study will provide valuable information on whether this medication can be beneficial for people with kidney and heart conditions who are undergoing hemodialysis.

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

    Joining the study

    Upon joining the study, you will be asked to provide your signed informed consent. This confirms your understanding and agreement to participate in the trial.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying that you are at least 18 years old, have been on maintenance hemodialysis three times a week for at least three months but not more than five years, and have a body mass index (BMI) of less than 45 kg/m² with stable weight over the past three months.

  3. Step 3

    Randomization

    You will be randomly assigned to receive either the active medication, Forxiga 10 mg film-coated tablets, or a placebo, which looks identical to the active medication but does not contain the active ingredient.

  4. Step 4

    Medication administration

    If you are assigned to the active medication group, you will take Forxiga 10 mg orally once daily. If you are in the placebo group, you will take the placebo in the same manner. This will continue for the duration of the trial.

  5. Step 5

    Regular monitoring

    Throughout the trial, regular monitoring will be conducted. This includes measuring changes in your heart's left ventricular mass, which is a key indicator of heart health. Other health markers such as blood pressure, body weight, and quality of life will also be assessed.

  6. Step 6

    Completion of trial

    The trial is expected to last until April 20, 2025. Upon completion, a final assessment will be conducted to evaluate the effects of the medication or placebo on your health.

Who can join the trial?

4 criteria

  • Age must be 18 years or older.
  • Currently receiving hemodialysis (a treatment for kidney failure that removes waste and extra fluid from the blood) 3 times a week for at least 3 months but not more than 5 years.
  • Body Mass Index (BMI) must be less than 45 kg/m² and your weight should have been stable (within ± 5 kg) over the last three months.
  • Must have signed an informed consent form, which means you understand the study and agree to participate.

Who cannot join the trial?

4 criteria

  • Patients with **Chronic Kidney Disease** cannot participate.
  • Patients with **Kidney Failure** are not eligible.
  • Individuals with **Left Ventricular Hypertrophy** cannot join. This is a condition where the muscle wall of the heart's left pumping chamber becomes thickened.
  • Patients undergoing **Hemodialysis** are excluded. Hemodialysis is a treatment that filters and purifies the blood using a machine, which is necessary when the kidneys are not functioning properly.
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Investigated drugs

Dapagliflozin is a medication used in this clinical trial. It belongs to a group of drugs called SGLT2 inhibitors. These medications help lower blood sugar levels in people with diabetes by helping the kidneys remove sugar from the body through urine. In this trial, dapagliflozin is being tested to see if it can also help improve heart health in patients who are on hemodialysis, whether they have diabetes or not. The study aims to find out if dapagliflozin can provide benefits beyond controlling blood sugar, particularly in protecting the heart.

What is already known about the treatment

Dapagliflozin – Dapagliflozin is a medication taken orally, typically in the form of a tablet, and is used to help manage certain kidney and heart conditions. It is currently being studied in clinical trials for its effects on patients undergoing hemodialysis, both with and without diabetes. The main therapeutic uses of dapagliflozin include treating chronic kidney disease, kidney failure, and heart-related issues like left ventricular hypertrophy. It works by inhibiting a protein in the kidneys called SGLT2, which helps reduce blood sugar levels and may have protective effects on the heart and kidneys. Dapagliflozin belongs to a class of drugs known as SGLT2 inhibitors, which are primarily used to manage blood sugar levels in people with diabetes.

Investigated diseases

  • Chronic Kidney Disease

    Chronic Kidney Disease is a long-term condition where the kidneys gradually lose their ability to filter waste and excess fluids from the blood. This disease progresses through stages, from mild damage in the early stages to severe damage in the later stages. As the disease advances, waste products can build up in the body, leading to symptoms such as fatigue, swelling, and high blood pressure. The progression can be slow, often taking years to reach advanced stages. It can eventually lead to complications affecting other organs and systems in the body.

  • Kidney Failure

    Kidney Failure, also known as renal failure, occurs when the kidneys lose their ability to function effectively. This condition can develop rapidly or progress over time, depending on the underlying cause. As the kidneys fail, waste products and fluids accumulate in the body, which can lead to symptoms like nausea, weakness, and fluid retention. The progression of kidney failure can lead to the need for dialysis or kidney transplantation. It is often the end stage of Chronic Kidney Disease.

  • Left Ventricular Hypertrophy

    Left Ventricular Hypertrophy is a condition where the muscle wall of the heart's left ventricle thickens. This thickening can occur as a response to increased workload on the heart, often due to high blood pressure or heart valve disease. As the condition progresses, the heart may become less efficient at pumping blood, leading to symptoms such as shortness of breath and chest pain. Over time, it can affect the heart's ability to function properly. The progression of this condition can lead to further cardiac complications.

  • Hemodialysis

    Hemodialysis is a medical procedure used to remove waste products and excess fluid from the blood when the kidneys are no longer able to perform these functions. This process involves circulating the blood through a machine that filters it before returning it to the body. Hemodialysis is typically required on a regular basis, often several times a week. The need for hemodialysis usually arises as kidney function declines significantly. It is a critical intervention for individuals with severe kidney impairment.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518591-31-00Estimated enrolment220 patientsSponsorMedical University Of Vienna

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