RecruitingPhase 3NCT03994471

Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.

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


Sponsor

Iperboreal Pharma Srl

Enrollment

170 participants

Start Date

Dec 14, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new peritoneal dialysis solution called XyloCore for people whose kidneys have permanently failed and who are already on a type of home dialysis called CAPD (continuous ambulatory peritoneal dialysis). The goal is to see if XyloCore is safe and works as well as standard dialysis fluids. **You may be eligible if...** - You are 18 or older - You have end-stage kidney disease and have been on CAPD for at least 3 months - Your condition has been stable — no unplanned hospitalizations or major heart events in the last 3 months - You have not had a peritoneal infection (peritonitis) in the last 3 months - You are already using a specific overnight dialysis solution called Extraneal for at least 1 month - Your dialysis is delivering adequate waste clearance (Kt/V urea > 1.7 per week) **You may NOT be eligible if...** - You have had peritonitis in the last 3 months - Your dialysis has not been working adequately - You have had a major cardiovascular event or hospitalization recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght

XyloCore Low Strenght: 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine - or - XyloCore Medium Strenght: 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine - or - XyloCore High Strenght: 2.0% Xylitol, 1.5% Glucose, and 0.02% L-carnitine

DRUG1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution

Physioneal 35 or 40 (including Clear-Flex bag), Fixioneal 35 or 40, Dianeal or Dianeal Low Calcium have 1.36%, 2.27% or 3.86% glucose; Balance, Bicavera, Bicanova or Equibalance have 1.25%, 2.3%, 4.5% glucose.


Locations(41)

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

Ospedale SS. Annunziata

Chieti, Italy

IRCCS Policlinico San Martino

Genova, Italy

Ospedale Civile San Salvatore

L’Aquila, Italy

ASST Fatebenefratelli-Sacco -Ospedale Luigi Sacco

Milan, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Azienda Ospedaliera Universitaria di Modena

Modena, Italy

AOU Università degli studi della Campania

Naples, Italy

Università della Campania L.Vanvitelli

Naples, Italy

Azienda Ospedaliera di Padova

Padova, Italy

Ospedale AUSL "Guglielmo da Saliceto"

Piacenza, Italy

Ospedale S.Eugenio

Roma, Italy

Ospedale C. e G. Mazzoni

San Benedetto del Tronto, Italy

Azienda Ospedaliera Terni

Terni, Italy

Ospedale San Giovanni Bosco

Torino, Italy

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, Italy

University Hospital A Coruña Fundación Profesor Novoa Santos

A Coruña, Spain

Hospital U. Germans Trias i Pujol

Badalona, Spain

Fundaciòn Puigvert

Barcelona, Spain

Hospital Universitario Josep Trueta

Girona, Spain

Fundacion Jimenez Diaz

Madrid, Spain

Hospital Ramón y Cajal

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Central De Asturias

Oviedo, Spain

Halland County Hospital of Halmstad

Halmstad, Sweden

Karolinska University Hospital

Stockholm, Sweden

Heartlands Hospital

Birmingham, United Kingdom

St Luke's Hospital

Bradford, United Kingdom

University Hospitals Sussex

Brighton, United Kingdom

Kent and Canterbury Hospital

Canterbury, United Kingdom

Hammersmith Hospital

London, United Kingdom

Churchill Hospital

Oxford, United Kingdom

Sheffield Kidney Institute

Sheffield, United Kingdom

University Hospitals of North Midlands

Stoke-on-Trent, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT03994471


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