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Study on the Safety of Glucothera Plus for Children 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 End-stage Kidney Disease in children. The treatment being tested is called Glucothera Plus, which is a solution used for a type of treatment known as peritoneal dialysis. Peritoneal dialysis is a way to clean the blood when the kidneys are not working well. Glucothera Plus contains several substances, including levocarnitine, magnesium chloride hexahydrate, sodium chloride, calcium chloride dihydrate, glucose monohydrate, and sodium lactate. These substances help in the dialysis process by maintaining the right balance of fluids and electrolytes in the body.

The purpose of this study is to demonstrate the safety of Glucothera Plus in children who have End-stage Kidney Disease. During the study, participants will receive the treatment and be monitored for any side effects. The study will also involve regular checks of blood pressure, weight, and other health indicators to ensure the treatment is safe. The study will last for a period of up to four months, during which the participants will undergo various assessments to monitor their health and the effectiveness of the treatment.

Participants in the study will be children who are already receiving peritoneal dialysis. The study will involve regular visits to the clinic for monitoring and assessments. These assessments will include tests to measure kidney function, blood chemistry, and overall health. The goal is to ensure that Glucothera Plus is a safe option for children with End-stage Kidney Disease who require peritoneal dialysis.

The research process

The trial runs in 4 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 must meet specific criteria, including being younger than 18 years old, having end-stage kidney disease, and undergoing continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for at least six months.

    The patient must have a plasma L-carnitine level of 30 nmol/ml or lower, a dwell volume between 800 ml/m² and 1200 ml/m² of body surface, and no peritonitis episodes in the last three months.

    Written informed consent is required to participate in the study.

  2. Step 2

    Treatment with glucothera plus

    The patient will receive Glucothera Plus, a solution for peritoneal dialysis, administered intraperitoneally.

    The treatment aims to demonstrate the safety of Glucothera Plus in children with end-stage kidney disease.

  3. Step 3

    Monitoring and assessments

    Throughout the study, safety is assessed through continuous reporting of any adverse events, including monitoring blood pressure and weight.

    Secondary assessments include measuring Kt/V urea, 24-hour peritoneal ultrafiltration, 24-hour urinary volume, and conducting a peritoneal equilibration test.

    Residual kidney function and plasma L-carnitine levels are evaluated at various points (V1, V2, and V3).

    Tolerability is assessed through blood chemistry and hematology tests at specific visits (V2, V3, and V4).

  4. Step 4

    Completion of the study

    The study is estimated to end by December 31, 2024.

    The recruitment for the study is expected to start on April 1, 2024.

Who can join the trial?

6 criteria

  • Male and female patients younger than 18 years old
  • Diagnosed with End-stage Kidney Disease (ESRD) and receiving treatment with Continuous Ambulatory Peritoneal Dialysis (CAPD) or Automated Peritoneal Dialysis (APD) for the last 6 months
  • L-carnitine plasma level is 30 nanomoles per milliliter or less. L-carnitine is a substance in the blood that helps the body turn fat into energy.
  • Dwell volume between 800 milliliters per square meter and 1200 milliliters per square meter of body surface. Dwell volume refers to the amount of dialysis fluid used in the treatment.
  • Have not experienced peritonitis episodes in the last 3 months. Peritonitis is an infection of the lining of the abdomen.
  • Provided written informed consent to participate in the study

Who cannot join the trial?

3 criteria

  • Patients with end-stage kidney disease cannot participate. This means their kidneys are no longer working well enough to meet the body's needs.
  • Patients who are not in the age range of 2 to 18 years old are excluded. This study is only for children and teenagers.
  • Patients who are not part of the vulnerable population selected for this study cannot participate. This refers to groups that may need special protection or care.
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Investigated drugs

Glucothera Plus is a medication being studied for its safety in children undergoing peritoneal dialysis. It is designed to help manage the process of dialysis, which is a treatment for kidney failure that removes waste products and excess fluid from the blood. The study aims to ensure that Glucothera Plus is safe for use in the pediatric population, meaning it is being tested to confirm that it does not cause harmful effects in children.

What is already known about the treatment

Glucothera Plus – This medication is administered through peritoneal dialysis, a method used to treat end-stage kidney disease, particularly in children. Currently, Glucothera Plus is under clinical investigation to assess its safety in pediatric patients, as part of ongoing research in medical literature. It is primarily indicated for managing end-stage kidney disease by facilitating the removal of waste products and excess fluid from the body. At the molecular level, Glucothera Plus works by enhancing the osmotic gradient, which aids in the efficient exchange of fluids and solutes across the peritoneal membrane. It is classified pharmacologically as a dialysis solution, specifically designed for use in peritoneal dialysis procedures.

Investigated diseases

End-stage Kidney Disease – This condition occurs when the kidneys are no longer able to function at a level needed for day-to-day life. It is the final stage of chronic kidney disease, where the kidneys have lost about 85-90% of their ability to work normally. As the disease progresses, waste products and excess fluid build up in the body, leading to symptoms such as fatigue, swelling, and difficulty concentrating. Patients may experience changes in urination patterns, high blood pressure, and electrolyte imbalances. The progression of the disease often requires interventions to manage symptoms and maintain quality of life.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-512078-88-00Protocol codeIP-001-21Estimated enrolment20 patientsSponsorIperboreal Pharma S.r.l.

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