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Study on XyloCore and Drug Combination for Patients with End-Stage Kidney Disease Undergoing Peritoneal Dialysis

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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 a condition known as End-Stage Kidney Disease, which is a severe form of kidney failure. The trial will evaluate a new treatment called XyloCore, which is an experimental solution used in a process called peritoneal dialysis. Peritoneal dialysis is a treatment that helps remove waste products from the blood when the kidneys are not functioning properly. The study aims to compare the effectiveness and safety of XyloCore with standard glucose-based solutions used in peritoneal dialysis.

Participants in the study will receive either the XyloCore solution or a standard glucose solution. The study will last for several months, during which participants will undergo regular assessments to monitor their health and the effectiveness of the treatment. These assessments will include tests to measure how well the dialysis is working, as well as checks on blood sugar and cholesterol levels, and evaluations of kidney function. Participants will also be asked about their energy levels and any side effects they may experience.

The purpose of this study is to determine if XyloCore is as effective as the standard treatments currently used for peritoneal dialysis. The study will help researchers understand if XyloCore can provide a safe and effective alternative for patients with End-Stage Kidney Disease. The trial is expected to continue until the end of 2025, with recruitment of participants having started in early 2023.

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, the patient is required to provide informed consent, acknowledging understanding of the study's nature and agreeing to participate.

    Eligibility criteria include being 18 years or older, having a diagnosis of end-stage kidney disease, and being treated with continuous ambulatory peritoneal dialysis (CAPD) for the last three months.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to ensure the patient is in stable clinical condition, demonstrated by the absence of non-elective hospitalizations and major cardiovascular events in the last three months.

    The patient must not have experienced peritonitis episodes in the last three months.

  3. Step 3

    Treatment regimen

    The patient will be treated with the experimental solution XyloCore, which is a glucose-sparing solution for peritoneal dialysis.

    The treatment involves intraperitoneal use of solutions such as balance, FIXIONEAL, bicaVera, PHYSIONEAL, Dianeal, and equiBalance with varying glucose concentrations (1.36%, 2.27%, 3.86%, 1.5%, 2.3%, 4.25%).

  4. Step 4

    Monitoring and assessments

    Throughout the study, the patient's weekly Kt/V urea will be measured at specific visits (V1, V3, V4, V5) to evaluate the efficacy of the treatment.

    Secondary assessments include monitoring glycemic and lipid metabolic parameters, EPO requirements, subjective assessment of fatigue, and 24-hour analyses of peritoneal dialysate and urine.

  5. Step 5

    Safety evaluations

    Safety is evaluated through physical examinations, vital signs, laboratory outcomes, and monitoring for any adverse events throughout the study duration.

    The study aims to demonstrate the non-inferiority of XyloCore compared to standard glucose peritoneal dialysis solutions.

  6. Step 6

    Study duration

    The estimated end date for the study is December 31, 2025.

    The recruitment for the study began on March 24, 2023.

Who can join the trial?

9 criteria

  • Must be **18 years or older**.
  • Must have a diagnosis of **End-Stage Kidney Disease (ESRD)** and have been treated with **Continuous Ambulatory Peritoneal Dialysis (CAPD)** in the last 3 months. CAPD is a type of dialysis that cleans the blood using the lining of the abdomen.
  • Must be in a **stable clinical condition** for the 3 months before screening, meaning no unexpected hospital stays or major heart-related events.
  • Must not have had any **peritonitis** episodes in the last 3 months. Peritonitis is an infection of the lining of the abdomen.
  • Must be using **Extraneal** for at least one month. Extraneal is a dialysis solution used overnight.
  • Must be using 1, 2, or 3 short-dwell exchanges with specific dialysis solutions like **Physioneal**, **Fixioneal**, **Dianeal**, or others. These are different types of dialysis fluids with varying glucose levels.
  • Must have a **weekly Kt/V urea measurement** greater than 1.7. This is a test that measures how well dialysis is cleaning the blood.
  • Must have been followed up or treated by the participating clinical center or investigator in the last three months.
  • Must understand the nature of the study and provide **informed consent** to participate. This means agreeing to join the study after being fully informed about it.

Who cannot join the trial?

10 criteria

  • Patients who are not diagnosed with End-Stage Kidney Disease. This is a condition where the kidneys no longer work well enough to meet the body's needs.
  • Patients who are not within the specified age range for the study. The study may have specific age requirements.
  • Patients who are not part of the specified clinical trial group. The study may be looking for participants with certain characteristics or conditions.
  • Patients who are not willing or able to follow the study procedures and requirements.
  • Patients who have other medical conditions that might interfere with the study or make participation unsafe.
  • Patients who are pregnant or breastfeeding, as the study may not be safe for them or their babies.
  • Patients who are participating in another clinical trial at the same time, as this could affect the results of the study.
  • Patients who have a history of allergic reactions to the study medication or similar medications.
  • Patients who have recently had a major surgery or are planning to have one during the study period.
  • Patients who have a history of substance abuse, as this could interfere with the study results.
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Investigated drugs

XyloCore is an experimental solution being tested for use in peritoneal dialysis. It is designed to spare glucose, which means it aims to reduce the amount of glucose absorbed by the body during dialysis. The goal of using XyloCore is to provide an alternative to standard glucose-based dialysis solutions, potentially offering a safer or more effective treatment option for patients undergoing peritoneal dialysis.

What is already known about the treatment

XyloCore – XyloCore is an experimental solution administered through peritoneal dialysis, a method used to treat patients with end-stage kidney disease. It is currently being evaluated in clinical trials to determine its efficacy and safety compared to standard glucose-based peritoneal dialysis solutions. The main therapeutic indication for XyloCore is to provide an alternative dialysis solution that spares glucose, potentially offering benefits for patients who require dialysis. At the molecular level, XyloCore works by facilitating the removal of waste products and excess fluid from the blood through the peritoneal membrane, similar to traditional dialysis solutions but with a different osmotic agent. It is classified pharmacologically as a dialysis solution, specifically designed to optimize the dialysis process while minimizing glucose exposure.

Investigated diseases

End-Stage Kidney Disease – This is the final stage of chronic kidney disease where the kidneys can no longer function adequately to meet the body's needs. As the disease progresses, waste products and excess fluids build up in the body, leading to symptoms such as fatigue, swelling, and difficulty concentrating. Patients may experience a decrease in urine output and require dialysis or a kidney transplant to perform the functions of the kidneys. The condition can affect various body systems, leading to complications like high blood pressure, anemia, and bone disease. Management focuses on controlling symptoms and maintaining quality of life. Regular monitoring and lifestyle adjustments are crucial to managing the disease's progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513562-19-00Protocol codeIP-001-18Estimated enrolment175 patientsSponsorIperboreal Pharma S.r.l.

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