Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.
NCT ID: NCT03994471
Last Updated: 2025-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
170 participants
INTERVENTIONAL
2022-12-14
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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XyloCore peritoneal dialysis solution
Patients will receive 1, 2 or 3 daily (short-dwell) exchanges with XyloCore of an osmotic strength comparable to their pre-randomization prescription of glucose peritoneal dialysis solution (XyloCore Low, Medium and High Strenght have an osmotic strength comparable to Physioneal, Fixioneal or Dianeal 1.36%, 2.27%, 3.86% glucose, respectively, and Balance, Bicavera, Bicanova or Equibalance with 1.5%, 2.5%, 4.25% glucose, respectively). All patients will receive Extraneal (7.5% Icodextrin) for nocturnal (long-dwell) exchange.
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
Glucose peritoneal dialysis solution
Patients randomized to glucose solution will continue the 1, 2 or 3 daily (short-dwell) exchanges of Physioneal 40 or 35, Fixioneal 40 or 35 or Dianeal (1.36%, 2.27%, 3.86% glucose), Balance, Bicavera, Bicanova or Equibalance (1.5%, 2.5%, 4.25% glucose) with the same osmotic strength of their pre-randomization prescription. All patients will receive Extraneal (7.5% Icodextrin) for nocturnal (long-dwell) exchange.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Iperboreal Pharma Srl
INDUSTRY
Responsible Party
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Principal Investigators
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Arduino Arduini, MD
Role: STUDY_DIRECTOR
Iperboreal Pharma
Werner Kleophas, MD
Role: STUDY_CHAIR
DaVita Deutschland AG
Locations
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ASST Spedali Civili di Brescia
Brescia, , Italy
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
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
Napoli, , Italy
Università della Campania L.Vanvitelli
Napoli, , Italy
Azienda Ospedaliera di Padova
Padua, , 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
Countries
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Central Contacts
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Facility Contacts
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Hanna Sofia Svensson, MD
Role: primary
Johan Povlsen, MD
Role: primary
Kirstine Møller Gliese, MD
Role: primary
Thilo Krueger, MD
Role: primary
Matthias Zeiler, MD
Role: primary
Rossella Cannavò, MD
Role: primary
Loreto Gesualdo, MD
Role: primary
Federico Alberici, MD
Role: primary
Francesca Cappadona, MD
Role: primary
Luca Piscitani, MD
Role: primary
Maurizio Gallieni, MD
Role: primary
Luca Nardelli, MD
Role: primary
Gabriele Donati, MD
Role: primary
Francesco Trepiccione, MD
Role: primary
Silvio Borrelli, MD
Role: primary
Anna Bass, MD
Role: primary
Roberto Scarpioni, MD
Role: primary
Roberto Palumbo, MD
Role: primary
Matthias Zailer, MD
Role: primary
Luigi Vecchi, MD
Role: primary
Dario Roccatello, MD
Role: primary
Giovanni Gambaro, MD
Role: primary
Miguel Perez Fontan, MD
Role: primary
Marie Troya Saborido, MD
Role: primary
Maria Alba Herreros, MD
Role: primary
Claudia Castillo Devia
Role: primary
Catalina Cleary, MD
Role: primary
Haridian Sosa Barrios, MD
Role: primary
Maria Bajo, MD
Role: primary
Marie Rodriguez Suarez, MD
Role: primary
Karl Bjurström, MD
Role: primary
Olof Heimbürger, MD
Role: primary
Jyoti Baharani, MD
Role: primary
Ahsan Syed, MD
Role: primary
Sarah Lawman, MD
Role: primary
Nilesh Kumar Shah, MD
Role: primary
Richard Corbett, MD
Role: primary
Udaya Udayaraj, MD
Role: primary
Martin Wilkie, MD
Role: primary
Mark Lambie, MD
Role: primary
Other Identifiers
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2019-004183-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IP-001-18
Identifier Type: -
Identifier Source: org_study_id
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