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Study on the Safety of Difelikefalin for Adolescents with Itching Due to Chronic Kidney Disease on 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 safety of a medication called difelikefalin in adolescents aged 12 to 17 years who are undergoing hemodialysis due to chronic kidney disease and are experiencing moderate-to-severe pruritus, which is a condition characterized by severe itching. The medication, known by its brand name Kapruvia, is administered as a solution for injection. The purpose of the study is to evaluate how safe this treatment is for young patients with these conditions.

Participants in the study will receive difelikefalin through an intravenous injection, which means the medication is delivered directly into a vein. The study will monitor the participants over a period to observe any side effects and to measure the levels of the medication in their blood. This will help determine how well the medication is tolerated by the body and how it behaves in the bloodstream.

The study is designed to ensure that the medication is safe for use in this specific group of patients. By participating, researchers aim to gather important information that could lead to better treatment options for adolescents suffering from itching related to long-term kidney disease. The study will continue until the estimated end date in 2029, allowing ample time to collect and analyze the data.

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 informed about the purpose and procedures involved. You will be asked to provide informed consent, which means you agree to participate after understanding the study details. If you are under 18, your legal guardian will also need to provide consent.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure you meet the study criteria. This includes confirming your age is between 12 and 17 years, and that you have been undergoing hemodialysis three times a week for at least 12 weeks. Your condition, known as chronic kidney disease, should be associated with moderate-to-severe pruritus (itching).

  3. Step 3

    Run-in period

    During a 7-day run-in period, you will be asked to record your itching severity using a tool called the WI-NRS (Worst Itching Numeric Rating Scale). This helps determine the average severity of your itching, which should be greater than 4.0 on the scale.

  4. Step 4

    Medication administration

    You will receive the study medication, difelikefalin, through an intravenous injection. The dosage is 0.5 micrograms per kilogram of your body weight. This medication is administered during your regular hemodialysis sessions.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, you will be monitored for any side effects, known as adverse events. Blood samples may be taken to measure the concentration of difelikefalin in your plasma before and after doses. This helps assess the medication's safety and how your body processes it.

  6. Step 6

    Completion of study

    The study is expected to continue until August 2029. Upon completion, you will undergo a final assessment to evaluate your overall health and any changes in your condition.

Who can join the trial?

9 criteria

  • Participant must be between 12 to 17 years old at the time of giving consent.
  • Participants must have Chronic Kidney Disease (CKD) and be on Hemodialysis (HD) three times a week for at least 12 weeks before giving consent. Hemodialysis is a treatment that filters and purifies the blood using a machine.
  • Participants must have a WI-NRS score recorded for at least 4 days during a 7-day period, with an average score of more than 4.0. WI-NRS is a scale used to measure the severity of itching.
  • In the last 3 months before screening, participants must have had at least one of the following:
    • At least two single-pool Kt/V measurements of 1.2 or higher on different dialysis days. Kt/V is a measure of dialysis treatment adequacy.
    • At least two urea reduction ratio measurements of 65% or higher on different dialysis days. This measures how well dialysis removes waste from the blood.
    • One single-pool Kt/V measurement of 1.2 or higher and one urea reduction ratio measurement of 65% or higher on different dialysis days.
    • Participants must have a prescription dry body weight of at least 20 kg. This is the weight of the body without excess fluid.
    • Participants must use contraception as per local regulations if applicable. Contraception refers to methods used to prevent pregnancy.
    • Participants and/or their legal guardian must be able to provide signed informed consent and, if appropriate, assent. Informed consent is a process of understanding the key facts about a clinical trial before deciding to participate.

Who cannot join the trial?

7 criteria

  • Patients with any other skin condition that could interfere with the study.
  • Patients who have had a recent infection or illness that could affect the study results.
  • Patients who are currently taking medications that might interfere with the study treatment.
  • Patients with a history of severe allergic reactions.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients with any condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

Difelikefalin is a medication being studied for its ability to help reduce itching in adolescents who are undergoing hemodialysis and experience moderate-to-severe pruritus, which is a condition characterized by intense itching. This medication is given through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. The main goal of using difelikefalin in this trial is to see if it is safe and well-tolerated by the patients, while also helping to alleviate their itching symptoms.

What is already known about the treatment

Difelikefalin – Difelikefalin is administered through an intravenous injection, meaning it is given directly into a vein. It is currently being studied in clinical trials, particularly for its safety and tolerability in adolescents aged 12 to 17 years who are on hemodialysis and suffer from moderate-to-severe itching, known as pruritus, often associated with chronic kidney disease. The main therapeutic use of difelikefalin is to relieve this severe itching. At the molecular level, it works by activating certain receptors in the body called kappa opioid receptors, which help reduce the sensation of itchiness. Difelikefalin is classified as a kappa opioid receptor agonist in pharmacology.

Investigated diseases

  • Pruritus

    Pruritus is a condition characterized by an uncomfortable sensation on the skin that provokes the urge to scratch. It can affect any part of the body and may be localized or widespread. The sensation is often described as tingling, irritating, or burning. Pruritus can be caused by a variety of factors, including dry skin, allergies, or systemic conditions. Over time, persistent scratching can lead to skin damage, such as redness, swelling, or thickening of the skin. The intensity of the itch can vary, and it may worsen at night or in response to certain triggers.

  • Chronic Kidney Diseases

    Chronic Kidney Diseases (CKD) refer to the gradual loss of kidney function over time. The kidneys become less effective at filtering waste and excess fluids from the blood, which can lead to a buildup of harmful substances in the body. CKD progresses through stages, from mild damage in the early stages to severe damage in the later stages. As the disease advances, symptoms such as fatigue, swelling, and changes in urination may occur. The progression of CKD can lead to complications like high blood pressure, anemia, and bone disease. The rate of progression can vary depending on the underlying cause and individual health factors.

Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IITrial ID2023-509909-74-00Protocol codeKOR-PED-202Estimated enrolment24 patientsSponsorVifor Fresenius Medical Care Renal Pharma Ltd.

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