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A study to test how well empagliflozin works and how safe it is for children and teenagers with chronic 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 chronic kidney disease in children and teenagers. Chronic kidney disease is a condition where the kidneys are damaged and cannot filter blood as well as they should. The study will test a medicine called empagliflozin, which is also known by the brand name Jardiance. Some participants will receive empagliflozin tablets, while others will receive placebo tablets that look the same but contain no active medicine. The medicine is taken by mouth as film-coated tablets.

The purpose of the study is to learn how empagliflozin works in the bodies of children and teenagers with chronic kidney disease, to see if it is safe for them, and to find out if it helps their kidney disease. The study will measure how much of the medicine gets into the blood, check for any unwanted effects, and see if the medicine helps improve kidney function. The study will look at changes in protein levels in the urine, which is one way to measure how well the kidneys are working, and changes in how well the kidneys filter waste from the blood.

The study has two parts. In the first part, participants will be randomly assigned to receive either empagliflozin or placebo for 24 weeks, and neither the participants nor the doctors will know which treatment they are receiving. After this period, there will be an open-label extension where all participants will know they are receiving empagliflozin. The total treatment period can last up to 72 weeks. During the study, participants will continue taking their regular medicines for kidney disease, which may include medicines that help protect the kidneys. Regular check-ups will be done to monitor the participants' health and kidney function throughout the study.

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

    Initial treatment period begins

    On Day 1, treatment begins after you have been assigned to receive either empagliflozin tablets or placebo tablets. Placebo tablets look like the actual medication but contain no active ingredient.

    The assignment to either empagliflozin or placebo is done randomly, and neither you nor your doctor will know which treatment you are receiving during this period. This is called a double-blind phase.

    You will take the tablets by mouth as instructed by the study doctor.

    Your current kidney disease treatment will continue unchanged during the study, as long as the dose has been stable for 30 days before starting.

  2. Step 2

    Treatment continues through Week 8

    You will continue taking your assigned tablets daily by mouth.

    During this time, the study team will monitor how your kidneys are functioning by measuring your eGFR, which stands for estimated glomerular filtration rate. This is a measure of how well your kidneys are filtering waste from your blood.

    You will attend scheduled visits as directed by the study team.

  3. Step 3

    Assessment at Week 24

    At Week 24, several measurements will be taken to evaluate how the treatment has affected your condition.

    The study team will measure changes in your UACR, which stands for urine albumin-to-creatinine ratio. This test shows how much protein is leaking into your urine, which is a sign of kidney damage.

    Your urine glucose levels will be measured. This shows how much sugar is present in your urine.

    Your UPCR, which stands for urine protein-to-creatinine ratio, will also be measured. This is another way to check for protein in your urine.

    A blood sample will be taken before your daily dose to measure the amount of empagliflozin in your blood.

    The study team will review any side effects or health problems you may have experienced since Day 1.

  4. Step 4

    Transition to open-label extension

    After Week 24, you may continue into an open-label extension phase. During this phase, both you and your doctor will know that you are receiving empagliflozin, not placebo.

    If you were receiving placebo during the first 24 weeks, you will now switch to empagliflozin tablets taken by mouth.

    If you were already receiving empagliflozin, you will continue taking it.

  5. Step 5

    Continuation of open-label treatment

    You will continue taking empagliflozin tablets daily by mouth during the open-label extension.

    At Week 26, another blood sample will be taken before your daily dose to measure empagliflozin levels in your blood.

    The study team will continue to monitor your kidney function by measuring eGFR over time.

    Regular assessments will be conducted to check for any side effects or health problems.

  6. Step 6

    End of treatment

    When you complete the treatment phase, you will stop taking the study tablets.

    For 7 days after your last dose, the study team will continue to monitor you for any side effects. This period is called the residual effect period.

    A final assessment will be conducted to evaluate your overall health and kidney function.

Who can join the trial?

6 criteria

  • Written permission must be signed and dated by the patient's parent or legal guardian (the person legally responsible for the child), and the patient must also agree to participate based on their age and understanding, following proper medical research rules before joining the trial.
  • The patient must be between 2 and 17 years old at the first screening visit.
  • The patient must have chronic kidney disease (long-term damage to the kidneys) of any cause, confirmed by blood and urine tests showing: kidney filtering ability between 20 and 90 (measured by eGFR, which shows how well the kidneys clean the blood), and a urine test showing protein levels of 300 or higher (measured by UACR, which indicates kidney damage).
  • The patient must have been receiving stable standard kidney disease treatment for 30 days before joining the study, with no plans to change the dose during the trial. This treatment typically includes one medication that protects the kidneys called a RAAS inhibitor (such as ARB or ACEi, which help control blood pressure and reduce kidney damage). An additional medication called a mineralocorticoid receptor antagonist may also be used if needed and has been at a stable dose.
  • If the patient is taking daily medications to suppress the immune system (the body's defense system) to treat the cause of their kidney disease, they must have been on a stable dose for 30 days before the first screening visit and continue until the second visit. If the patient is taking specific medications called rituximab or cyclophosphamide, they must not have taken these for at least 120 days before the first screening visit.
  • Additional requirements may apply for participation in this study.

Who cannot join the trial?

1 criterion

  • The study does not list specific reasons why patients cannot participate, as the exclusion criteria (conditions or situations that prevent someone from joining the study) have not been provided in the available information.
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Investigated drugs

  • Empagliflozin

    is a medication given as a tablet by mouth. It is being tested in children and teenagers with chronic kidney disease to see how their body processes the medication, whether it is safe, and if it helps slow down the worsening of their kidney condition.

  • Placebo

    is an inactive treatment that looks like the real medication but contains no active medicine. It is used in this study to compare against empagliflozin to better understand if the real medication is working.

What is already known about the treatment

Empagliflozin – Empagliflozin 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. It is currently approved for use in adults and is being studied in children aged 2 to 17 years with chronic kidney disease that may get worse over time. At the molecular level, this medicine blocks a specific protein in the kidneys called sodium-glucose cotransporter 2, which normally helps the body reabsorb sugar back into the bloodstream. This clinical trial is investigating whether empagliflozin is safe and effective for protecting kidney function in pediatric patients with chronic kidney disease.

Investigated diseases

Chronic Kidney Disease – Chronic kidney disease is a long-term condition where the kidneys gradually lose their ability to filter waste products and excess fluids from the blood. In children, this disease can develop due to birth defects of the kidneys or urinary tract, inherited disorders, or damage from infections and other illnesses. As the disease progresses, waste products build up in the body, which can affect growth, development, and overall health. The kidneys become less effective at maintaining the proper balance of minerals and fluids in the body over time. In pediatric patients, chronic kidney disease may advance at different rates depending on the underlying cause and individual factors. Without proper management, the kidney function continues to decline, potentially leading to more severe stages of the disease.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-512577-27-00Protocol code1245-0256Estimated enrolment125 patientsSponsorBoehringer Ingelheim Espana S.A.

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