Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.

Trial details

Who runs it

Iperboreal Pharma Srl

Trial code

NCT03994471

Record updated

24 March 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: Age ≥18 years; Diagnosed with 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 hospitalization and major cardiovascular events; Have not experienced peritonitis episodes in the last 3 months; In treatment with prescribed Extraneal (nocturnal exchange bag solution) for at least 1 month; 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); Kt/V urea measurement > 1.7 per week at Baseline Visit; Followed/treated by the participating clinical Center/Investigator in the last three months; Understanding the nature of the study and providing their informed consent to participation.

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

ClinicalTrials.gov NCT03994471