Evaluation of Safety and Efficacy of PolyCore, a Combination of Xylitol, L-Carnitine, and Polydextrin, in End-Stage Kidney Disease Patients Initiating Peritoneal Dialysis

The primary objective of this pilot study is to evaluate the **safety** of PolyCore, a ternary combination of xylitol, L-carnitine, and polydextrin, in patients with **End-Stage Kidney Disease** initiating peritoneal dialysis. This is achieved through continuous monitoring of adverse events, vital signs, and laboratory parameters. The clinical relevance of this objective lies in ensuring that PolyCore is a safe treatment option for this patient population, potentially improving their management and outcomes.

The secondary objective is to assess the efficacy of PolyCore in maintaining adequate depuration, ultrafiltration, and sodium removal. This evaluation is crucial for determining the therapeutic effectiveness of PolyCore in enhancing dialysis efficiency and patient well-being.

The clinical trial involves participants diagnosed with **End-Stage Kidney Disease**. The study population includes both male and female adults, with an age range that encompasses middle-aged to older adults. Participants are required to be in stable clinical conditions and undergoing peritoneal dialysis for less than six months at the time of screening. The trial population was selected based on specific inclusion criteria, such as a glomerular filtration rate (GFR) of at least 5 and a weekly Kt/V urea of 1.7 or higher. Participants are also required to be on an incremental peritoneal dialysis treatment regimen involving daily Icodextrin and glucose-based solutions. The sponsor has not provided the total number of participants involved in the study. The trial includes a vulnerable population, indicating additional ethical considerations in the study design. Lifestyle factors such as diet and physical activity are not specified in the available data.

The clinical trial is designed to evaluate the safety and efficacy of **PolyCore**, a solution for peritoneal dialysis, in patients with **End-Stage Kidney Disease**. This study is a Phase IV, randomized, double-blind, controlled trial. The trial is expected to commence on June 1, 2025, and conclude by June 1, 2027. Participants will be involved in the study for a maximum treatment period of one month, with a daily dose of up to 4 liters of the investigational product administered intraperitoneally.

The study will include several visits, starting with a screening visit to confirm eligibility based on criteria such as a glomerular filtration rate (GFR) of at least 5, stable clinical conditions, and informed consent. Participants must be adults undergoing peritoneal dialysis for less than six months. The baseline visit will follow, where initial assessments will be conducted. Subsequent follow-up visits will occur regularly to monitor safety and efficacy endpoints, including adverse events, vital signs, blood chemistry, and weekly Kt/V urea. The end-of-study visit will finalize data collection and assess the overall outcomes.

Participants may be withdrawn from the study if they experience significant adverse events or if the investigational product is deemed ineffective. The primary endpoints focus on safety, with continuous monitoring of adverse events and laboratory parameters. Secondary endpoints include the evaluation of peritoneal ultrafiltration, sodium removal, and quality of life assessments. The study aims to provide comprehensive data on the safety profile of PolyCore in the specified patient population.

The clinical trial involves the administration of **PolyCore**, an investigational medicinal product formulated as a **solution for peritoneal dialysis**. PolyCore is designed for **intraperitoneal use** and is intended to treat patients with end-stage kidney disease initiating peritoneal dialysis. The solution comprises a combination of active substances, including **levocarnitine**, **magnesium chloride hexahydrate**, **sodium chloride**, **calcium chloride dihydrate**, **lactic acid**, **xylitol**, and **polydextrose**. The maximum daily dose of PolyCore is 4 liters, with a total treatment period of up to one day. The administration schedule is determined based on the patient's clinical condition and dialysis requirements.

PolyCore is not a pediatric formulation and is not classified as an orphan drug. The primary objective of the trial is to evaluate the safety of PolyCore through continuous monitoring of adverse events, vital signs, and laboratory parameters. The trial does not include any non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatment. Participant compliance with the dosing regimen is monitored through regular assessments and documentation of dialysis sessions. The investigational product is manufactured by IPERBOREAL PHARMA S.R.L., and its chemical nature is consistent with its intended use as a solution for peritoneal dialysis.

The efficacy of the investigational product, PolyCore, in treating patients with **End-Stage Kidney Disease** undergoing peritoneal dialysis will be assessed through a series of primary and secondary endpoints. Primary endpoints include the evaluation of adverse events, physical examinations, vital signs, body weight, blood chemistry, hematology, 24-hour diuresis analysis, 24-hour dialysate analysis, weekly Kt/V urea, and residual kidney function. These parameters will be measured at every visit throughout the study duration.

Secondary endpoints will focus on the post-baseline profile of weekly Kt/V urea, peritoneal ultrafiltration, peritoneal and total sodium removal, glycemic and lipidic parameters, and peritoneal clearances of creatinine, phosphate, and B2-microglobulin. Additionally, the quality of life will be assessed using the KDQOL-SF instrument at specified visits (V2, V4). The number of patients who drop out of the study for safety and efficacy reasons will also be recorded. These secondary endpoints will be evaluated at every visit, with peritoneal ultrafiltration also being monitored daily by patient diary.