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Comparing a new peritoneal dialysis solution to standard glucose solutions for kidney disease patients

A Study to EvaLuate the EffIcacy and Safety of XyloCore, a Glucose SparIng ExpeRimental Solution, for Peritoneal Dialysis

Phase 3 Interventional Iperboreal Pharma Srl · NCT03994471

This study is testing a new low glucose dialysis solution called XyloCore to see if it works better than standard glucose solutions for patients with End-Stage Renal Disease on peritoneal dialysis.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment170 (estimated)
Ages18 Years and up
SexAll
SponsorIperboreal Pharma Srl Industry-sponsored
Locations41 sites (Aalborg and 40 other locations)
Trial IDNCT03994471 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of XyloCore, a low glucose peritoneal dialysis solution, in patients with End-Stage Renal Disease (ESRD) undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD). It is a multicenter, randomized, controlled study that compares XyloCore to standard glucose solutions over a 6-month period. Patients will be randomly assigned to receive either XyloCore or their prescribed glucose-based solutions, with adjustments made to their dialysis prescriptions as needed to meet treatment goals. The study aims to assess the impact of XyloCore on patient outcomes compared to traditional treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with ESRD who have been treated with CAPD for at least 3 months.

Not a fit: Patients with a history of drug or alcohol abuse may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective peritoneal dialysis solution that improves patient outcomes in ESRD.

How similar studies have performed: Other studies have shown promise in using alternative dialysis solutions, but the specific approach of XyloCore is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
INCLUSION CRITERIA:

1. Age ≥18 years
2. Diagnosed with ESRD and treated with CAPD in the last 3 months
3. In stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalization and major cardiovascular events
4. Have not experienced peritonitis episodes in the last 3 months
5. In treatment with prescribed Extraneal (nocturnal exchange bag solution) for at least 1 month
6. In treatment with 1, 2 or 3 diurnal exchange bag solution of prescribed Phisioneal (including Clear-Flex bag), Fixioneal, Dianeal or Dianeal Low Calcium (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.25%, 2.3%, 4.5% glucose)
7. Kt/V urea measurement \> 1.7 per week at Baseline Visit
8. Followed/treated by the participating clinical Center/Investigator in the last three months
9. Understanding the nature of the study and providing their informed consent to participation.

EXCLUSION CRITERIA:

1. History of drug or alcohol abuse in the six months prior to entering the protocol
2. In treatment with androgens
3. Clinically significant abnormal liver function test (ɣ-GT \> 4 times the upper normal limit)
4. Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)
5. Expected patient's survival shorter than the trial duration
6. History of L-Carnitine therapy or use in the month prior to entering the protocol
7. Have used any investigational drug in the 3 months prior to entering the protocol
8. Female patients who are pregnant or breast-feeding.
9. Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception
10. Patients affected by Primary Hyperoxaluria as per known medical therapy
11. Patients with serum levels of uric acid \> 7.2 mg/dl (male and postmenopausal women) or \> 6.0 mg/dl (premenopausal women)
12. Patients with a major cardiovascular event in the last 3 months
13. Patients with advanced cardiac failure (NYHA 4)
14. Hypersensitivity to any of the constituents of the study IMPs.
15. Any contraindication to the prescribed Peritoneal Dialysis solutions (for long-dwell and short-dwell exchange) as per each product SmPC.
16. Participants with medical history of oxalate or lactate abnormalities considered clinically significant by the investigator.
17. 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.

Where this trial is running

Aalborg and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions End Stage Renal Diseaseperitoneal dialysisESRD
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.