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Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.

RecruitingPhase 3Ages 18 Years - anyAllIperboreal Pharma Srl
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In plain words

What the trial is, and whether it could suit you

Randomized, controlled, parallel groups, open-label, blinded end-point assessment, multicenter study, comparing the effects of a low glucose peritoneal dialysis solution, XyloCore, to glucose solutions (Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova or Equibalance) only regimen, in patients with End-Stage Renal Disease (ESRD) receiving Continuous Ambulatory Peritoneal Dialysis (CAPD), over a 6-month study period.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght
  • 1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution
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Where

41 sites
Aalborg University
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Zealand University Hospital
Roskilde, Denmark
Dialysis Center DaVita
Düsseldorf, Germany
Ospedale Madonna del Soccorso
Ascoli Piceno, Italy
Ospedale Santa Maria Annunziata
Bagno a Ripoli, Italy
Azienda Universitaria Ospedaliera di Bari
Bari, Italy
ASST Spedali Civili di Brescia
Brescia, Italy

…and 33 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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