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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Zealand University Hospital
  Roskilde, Denmark Recruiting
• Dialysis Center DaVita
  Düsseldorf, Germany Recruiting
• Ospedale Madonna del Soccorso
  Ascoli Piceno, Italy Recruiting
• Azienda Universitaria Ospedaliera di Bari
  Bari, Italy Recruiting
• Ospedale SS. Annunziata
  Chieti, Italy Recruiting

Study contacts

• Study coordinator: Arduino Arduini, MD
• Email: a.arduini@iperboreal.com
• Phone: +39.333.6409595

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.