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Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.
Sponsor: Iperboreal Pharma Srl
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.
Official title: A Study to EvaLuate the EffIcacy and Safety of XyloCore, a Glucose SparIng ExpeRimental Solution, for Peritoneal Dialysis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
170
Start Date
2022-12-14
Completion Date
2027-04-28
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
XyloCore 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
1.36%, 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