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Study on the Safety and Effectiveness of PolyCore (Xylitol, L-Carnitine, Polydextrin) for Patients with End-Stage Kidney Disease Starting 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, a condition where the kidneys can no longer function properly on their own. The trial will use a treatment called PolyCore, which is a special solution designed for peritoneal dialysis. Peritoneal dialysis is a treatment that uses the lining of the abdomen to filter waste from the blood when the kidneys are not working well. PolyCore contains several substances, including levocarnitine, magnesium chloride hexahydrate, sodium chloride, calcium chloride dihydrate, lactic acid, xylitol, and polydextrose.

The purpose of this study is to evaluate the safety of PolyCore in patients who are starting peritoneal dialysis. The study will monitor participants for any side effects and changes in their health. Participants will receive the PolyCore solution through a process called intraperitoneal use, which means it is administered into the abdominal cavity. The study will involve regular check-ups where doctors will examine the participants, check their vital signs, and perform blood tests to ensure their safety.

Throughout the study, participants will have their kidney function and overall health closely monitored. This includes regular assessments of their blood chemistry, body weight, and the effectiveness of the dialysis treatment. The study aims to gather information on how well PolyCore works and how safe it is for people with End-Stage Kidney Disease who are undergoing peritoneal dialysis. The trial is expected to continue until 2027, providing valuable insights into the treatment of this serious condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, an initial visit is conducted. During this visit, a physical examination is performed to assess overall health.
Vital signs such as blood pressure, heart rate, and body weight are measured. Blood and urine samples are collected for laboratory tests.
A 24-hour urine collection is required to analyze kidney function. A 24-hour dialysate collection is also needed to evaluate dialysis effectiveness.
Step 2
Treatment phase
The treatment involves using a solution called PolyCore for peritoneal dialysis. This solution is administered through the abdominal cavity.
The solution contains ingredients such as levocarnitine, magnesium chloride hexahydrate, sodium chloride, calcium chloride dihydrate, lactic acid, xylitol, and polydextrose.
The frequency and dosage of the solution are determined by the study protocol and are administered as part of the regular dialysis routine.
Step 3
Regular follow-up visits
Regular follow-up visits are scheduled throughout the study. During these visits, physical examinations are repeated to monitor health status.
Vital signs and body weight are checked at each visit. Blood and urine samples are collected for ongoing laboratory analysis.
The effectiveness of dialysis is evaluated by measuring the weekly clearance of urea, a waste product removed by the kidneys.
Step 4
Monitoring and evaluation
Throughout the study, any adverse events or side effects are continuously monitored to ensure safety.
The study aims to assess the safety and effectiveness of the PolyCore solution in treating end-stage kidney disease.
Quality of life is evaluated using a questionnaire designed to measure the impact of kidney disease on daily living.
Step 5
End of study
At the end of the study, a final visit is conducted to perform a comprehensive health assessment.
The results of the study are analyzed to determine the safety and efficacy of the treatment.
Participants are informed about the findings and any potential implications for their ongoing care.

Who can join the trial?

6 criteria

Adults with End-Stage Kidney Disease.
GFR (a measure of kidney function) must be at least 5.
Patients must have been receiving peritoneal dialysis (a treatment for kidney failure) for less than 6 months and be in stable health.
Patients must be on a specific incremental PD treatment plan, which includes using one daily solution based on Icodextrin (7.5%) and one daily solution based on glucose (up to 1.5%).
Patients must understand the study and agree to participate by giving informed consent.
Patients must have a weekly Kt/V urea (a measure of dialysis effectiveness) of at least 1.7.

Who cannot join the trial?

4 criteria

Patients with **End-Stage Kidney Disease** cannot participate.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate.
Patients who are part of a vulnerable population may not be eligible.

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Verified sites

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Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy
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Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Naples, Italy
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Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate
Chieti, Italy

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Investigated drugs

Xylitol
is a natural sugar alcohol commonly found in fruits and vegetables. In this trial, it is being used as part of a combination therapy to help manage end-stage kidney disease in patients who are starting peritoneal dialysis. Xylitol is known for its ability to improve oral health and has been included in this study to explore its potential benefits in kidney disease management.
L-Carnitine
is a substance that the body uses to turn fat into energy. It is naturally produced in the body and can also be found in some foods. In this clinical trial, L-Carnitine is being tested as part of a combination therapy to see if it can help improve the health of patients with end-stage kidney disease who are beginning peritoneal dialysis. The goal is to determine if L-Carnitine can support better energy levels and overall health in these patients.
Polydextrin
is a type of carbohydrate that is often used as a dietary fiber. It is included in this trial as part of a combination therapy to assess its effects on patients with end-stage kidney disease starting peritoneal dialysis. The study aims to find out if Polydextrin can help improve digestive health and support the overall well-being of these patients.

What is already known about the treatment

PolyCore – PolyCore is a medication administered orally, designed as a combination of three substances: Xylitol, L-Carnitine, and Polydextrin. It is currently being studied in clinical trials to assess its safety and effectiveness for patients with end-stage kidney disease who are beginning peritoneal dialysis. The main therapeutic goal of PolyCore is to support kidney function and improve patient outcomes during dialysis. At the molecular level, the components of PolyCore work together to enhance energy production and reduce harmful substances in the body. It is classified pharmacologically as a dietary supplement aimed at supporting kidney health.

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 function. 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 a decrease in urine output and may require dialysis or a kidney transplant to manage the condition. The progression of the disease can lead to complications such as high blood pressure, anemia, and bone disease. Regular monitoring and management are essential to address these complications and maintain quality of life.