XyloCore Solution Tested in Adults With End-Stage Kidney Disease on Dialysis

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