Evaluation of XyloCore Efficacy and Safety Compared to Standard Glucose Solutions in Peritoneal Dialysis for End-Stage Kidney Disease Patients
- Trial ID
- 2024-513562-19-00
- Protocol
- IP-001-18
- Sponsor
- Iperboreal Pharma S.r.l.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to demonstrate the non-inferiority of **XyloCore** compared to the standard treatment of glucose peritoneal dialysis (PD) solutions, with regards to the weekly Kt/V urea in patients with **End-Stage Kidney Disease**. This is clinically relevant as it aims to establish an alternative treatment option that may offer similar efficacy in dialysis adequacy, potentially improving patient outcomes and quality of life.
Secondary objectives include evaluating changes in various metabolic and physiological parameters, which are critical for comprehensive patient management. These include:
- Changes in LDL, HDL, total cholesterol, serum triglycerides, HbA1c, and insulin levels.
- Changes in hemoglobin levels and erythropoietin (EPO) requirements.
- Patients’ subjective assessment of fatigue using the Chalder Fatigue Scale.
- Changes in peritoneal ultrafiltration and blood pressure.
- Changes in diuresis and residual kidney function.
- Overall patient safety.
Participants
The clinical trial involves a total of **15 participants** diagnosed with **End-Stage Kidney Disease** (ESKD). The study population includes both male and female subjects aged 18 years and older. Participants are required to be in a stable clinical condition, having been treated with Continuous Ambulatory Peritoneal Dialysis (CAPD) for the last three months, and must not have experienced any peritonitis episodes during this period. The trial population was selected based on their treatment with specific dialysis solutions, such as Extraneal and Physioneal, and their weekly Kt/V urea measurement exceeding 1.7. Participants are also required to have been followed up or treated by the participating clinical center or investigator in the last three months. The study includes individuals who are considered a vulnerable population, and all participants have provided informed consent to partake in the study. Lifestyle considerations such as diet and physical activity are not specified in the available data.
Plans and Procedures
The clinical trial is designed to evaluate the efficacy and safety of a glucose-sparing experimental solution, XyloCore, for **peritoneal dialysis** in patients with **end-stage kidney disease**. This study is structured as a randomized, double-blind, controlled trial, aiming to demonstrate the non-inferiority of XyloCore compared to standard glucose peritoneal dialysis solutions. The trial is expected to run from March 24, 2023, to December 31, 2025, with participant involvement lasting up to 6 months.
Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age, diagnosis, and treatment history. Follow-up visits will occur at specified intervals to monitor primary and secondary endpoints, including weekly Kt/V urea, glycemic and lipid metabolic parameters, and safety assessments. The end-of-study visit will conclude the participant's involvement, ensuring all data is collected and any adverse events are addressed.
Participants are expected to remain in the study for the full duration unless conditions arise that necessitate early termination, such as non-compliance with the protocol or the occurrence of significant adverse events. The trial's methodology ensures rigorous data collection and analysis, maintaining the integrity and reliability of the study outcomes.
Treatment
The clinical trial involves the evaluation of **XyloCore**, an experimental solution for peritoneal dialysis. XyloCore is available in three formulations: Low Strength, Medium Strength, and High Strength. Each formulation contains the active substances **levocarnitine**, **glucose monohydrate**, and **xylitol**. The pharmaceutical form is a solution for peritoneal dialysis, administered via intraperitoneal use. The maximum daily dose is 6 liters, with a total treatment period of up to 6 months. Participant compliance is monitored through regular assessments of dosing schedules and adherence to the treatment regimen.
In addition to XyloCore, the trial includes several comparator treatments, which are standard glucose-based peritoneal dialysis solutions. These include products such as **balance**, **equiBalance**, **PHYSIONEAL**, **bicaVera**, **FIXIONEAL**, and **Dianeal**. Each of these solutions contains a combination of active substances, including **sodium hydrogen carbonate**, **magnesium chloride hexahydrate**, **sodium chloride**, **calcium chloride dihydrate**, **glucose monohydrate**, and **sodium s-lactate solution**. The solutions are also administered intraperitoneally, with a maximum daily dose of 6 liters and a treatment period of up to 6 months. Compliance with these treatments is similarly monitored to ensure adherence to the prescribed dosing schedules.
Efficacy
The efficacy of the clinical trial will be assessed primarily through the measurement of the weekly **Kt/V urea**. This parameter will be evaluated at specific timepoints, namely V1, V3, V4, and V5, to determine the non-inferiority of XyloCore compared to standard glucose peritoneal dialysis (PD) solutions. Secondary endpoints include the assessment of glycemic and lipid metabolic parameters such as LDL, HDL, total cholesterol, serum triglycerides, and insulin, also measured at V1, V3, V4, and V5. Additionally, EPO requirements and patients' subjective assessment of fatigue will be evaluated at V1, V3, and V5. Comprehensive 24-hour analyses of peritoneal dialysate and urine will be conducted to measure volume, ultrafiltration, urea, and creatinine at V1, V3, V4, and V5. Residual kidney function will also be assessed at these timepoints.
Safety will be monitored throughout the entire study via physical examinations, vital signs, laboratory outcomes, and the recording of any adverse events. The trial is designed to ensure rigorous data collection and analysis, adhering to the highest standards of clinical research. The endpoints and parameters have been selected to provide a comprehensive evaluation of the efficacy and safety of the experimental solution, XyloCore, in the context of peritoneal dialysis.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Age ≥18 years
- Diagnosis of ESRD and treated with CAPD in the last 3 months
- In stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalisation and major cardiovascular events
- Have not experienced peritonitis episodes in the last 3 months
- In treatment with Extraneal (nocturnal long-dwell exchange for at least one month)
- In treatment with 1, 2 or 3 short-dwell prescribed exchanges with Physioneal (including Clear-Flex bag), Fixioneal, Dianeal or Dianeal Low Calcium (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.5%, 2.3%, 4.25% glucose)
- Weekly Kt/V urea measurement > 1.7
- Followed-up/treated by the participating clinical Center/Investigator in the last three months
- Understanding the nature of the study and providing informed consent to participate in the study
Exclusion Criteria
- History of drug or alcohol abuse in the six months prior to entering the protocol
- In treatment with androgens
- Clinically significant abnormal liver function test (Gamma-GT and/or AST and/or ALT > 2 UNL; and/or total bilirubin > 3 UNL)
- Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low tract urinary infections, renal parenchymal infection, pericarditis, etc)
- Expected patient’s survival shorter than trial duration
- L-Carnitine therapy in the month prior to entering the protocol
- Have used any investigational drug in the 3 months prior to entering the protocol
- Female patients who are pregnant or breast-feeding
- Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception
- Patients affected by Primary Hyperoxaluria as per known medical history
- Patients affected by gout, who have had one or more flares of gout during the last 12 months before the screening, with serum levels of uric acid > 7.2 mg/dl (male and postmenopausal women) or > 6.0 mg/dl (premenopausal women)
- Patients with a major cardiovascular event in the last 3 months
- Patients with advanced cardiac failure (NYHA 4)
- Hypersensitivity to any of the constituents of the study IMPs
- Any contraindication to the prescribed Peritoneal Dialysis solutions (for long-dwell and short-dwell exchange) as per each product SmPC
- Participants with medical history of oxalate or lactate abnormalities considered clinically significant by the investigator
- History or evidence of any other medical, neurological or psychological condition that would expose the subject to an undue risk of a significant AE or interfere with study assessments during the course of the trial as determined by the clinical judgment of the investigator
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Denmark | Not Recruiting | 24 Mar 2023 | 20 |
 Germany | Not Recruiting | 24 Mar 2023 | 15 |
 Italy | Recruiting | 24 Mar 2023 | 75 |
 Spain | Recruiting | 24 Mar 2023 | 40 |
 Sweden | Recruiting | 24 Mar 2023 | 10 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
bicaVera 1,5 % Glucose, 1,75 mmol/l Calcium, Peritonealdialyselösung | Comparator | PERITONEALDIALYSELÖSUNG | INTRAPERITONEAL USE | 6 | 6 | PRD735504 |
equiBalance 2,3% glucosio, 1,75 mmol/l calcio, soluzione per dialisi peritoneale | Comparator | SOLUZIONE PER DIALISI PERITONEALE | INTRAPERITONEAL USE | 6 | 6 | PRD973476 |
PHYSIONEAL 35 Glucose 3,86 % w/v / 38,6 mg/ml, Peritonealdialyselösung | Comparator | PERITONEALDIALYSELÖSUNG | INTRAPERITONEAL USE | 6 | 6 | PRD1606206 |
PHYSIONEAL 40 Glucose 2,27 % w/v / 22,7 mg/ml, Peritonealdialyselösung | Comparator | PERITONEALDIALYSELÖSUNG | INTRAPERITONEAL USE | 6 | 6 | PRD1606229 |
balance 4,25% Glucose, 1,25 mmol/l Calcium, Peritonealdialyselösung | Comparator | PERITONEALDIALYSELÖSUNG | INTRAPERITONEAL USE | 6 | 6 | PRD792708 |
FIXIONEAL “35 Glucosio 2,27% p/v/22,7 mg/ml” in sacca Clear-Flex, Soluzione per dialisi peritoneale | Comparator | SOLUZIONE PER DIALISI PERITONEALE | INTRAPERITONEAL USE | 6 | 6 | PRD313064 |
PHYSIONEAL 35 Glucose 1,36 % w/v / 13,6 mg/ml, Peritonealdialyselösung | Comparator | PERITONEALDIALYSELÖSUNG | INTRAPERITONEAL USE | 6 | 6 | PRD1606200 |
Xylocore Medium Strength | Test | SOLUTION FOR PERITONEAL DIALYSIS | INTRAPERITONEAL USE | 6 | 6 | PRD11291893 |
PHYSIONEAL 35 Glucose 2,27 % w/v / 22,7 mg/ml, Peritonealdialyselösung | Comparator | PERITONEALDIALYSELÖSUNG | INTRAPERITONEAL USE | 6 | 6 | PRD1606203 |
Xylocore High Strength | Test | SOLUTION FOR PERITONEAL DIALYSIS | INTRAPERITONEAL USE | 6 | 6 | PRD11291894 |