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Clinical Trials in the UK / NCT03994471
Recruiting Phase 3

Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.

NCT03994471 · tracked via the Priya Life Science UK tracker
Sponsor
Iperboreal Pharma Srl
Phase
Phase 3
Started
2022-12-14
Last updated
2026-03-24

Condition(s) studied

End Stage Renal Disease

Investigational drug(s) / intervention(s)

XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
INCLUSION CRITERIA: 1. Age ≥18 years 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: 1. History of drug or alcohol abuse in the six months prior to entering the protocol 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.

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
Aalborg University Aalborg Denmark Not Yet Recruiting
Aarhus University Hospital Aarhus Denmark Recruiting
Zealand University Hospital Roskilde Denmark Recruiting
Dialysis Center DaVita Düsseldorf Germany Recruiting
Ospedale Madonna del Soccorso Ascoli Piceno Italy Recruiting
Ospedale Santa Maria Annunziata Bagno a Ripoli Italy Not Yet Recruiting
Azienda Universitaria Ospedaliera di Bari Bari Italy Recruiting
ASST Spedali Civili di Brescia Brescia Italy Not Yet Recruiting
Ospedale SS. Annunziata Chieti Italy Recruiting
IRCCS Policlinico San Martino Genova Italy Not Yet Recruiting
Ospedale Civile San Salvatore L’Aquila Italy Recruiting
ASST Fatebenefratelli-Sacco -Ospedale Luigi Sacco Milan Italy Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy Not Yet Recruiting
Azienda Ospedaliera Universitaria di Modena Modena Italy Recruiting
AOU Università degli studi della Campania Naples Italy Recruiting
Università della Campania L.Vanvitelli Naples Italy Recruiting
Azienda Ospedaliera di Padova Padova Italy Not Yet Recruiting
Ospedale AUSL "Guglielmo da Saliceto" Piacenza Italy Recruiting
Ospedale S.Eugenio Roma Italy Not Yet Recruiting
Ospedale C. e G. Mazzoni San Benedetto del Tronto Italy Recruiting
Azienda Ospedaliera Terni Terni Italy Recruiting
Ospedale San Giovanni Bosco Torino Italy Recruiting
Azienda Ospedaliera Universitaria Integrata di Verona Verona Italy Recruiting
University Hospital A Coruña Fundación Profesor Novoa Santos A Coruña Spain Recruiting
Hospital U. Germans Trias i Pujol Badalona Spain Recruiting
Fundaciòn Puigvert Barcelona Spain Recruiting
Hospital Universitario Josep Trueta Girona Spain Recruiting
Fundacion Jimenez Diaz Madrid Spain Recruiting
Hospital Ramón y Cajal Madrid Spain Not Yet Recruiting
Hospital Universitario La Paz Madrid Spain Recruiting
Hospital Universitario Central De Asturias Oviedo Spain Recruiting
Halland County Hospital of Halmstad Halmstad Sweden Recruiting
Karolinska University Hospital Stockholm Sweden Recruiting
Heartlands Hospital Birmingham United Kingdom Recruiting
St Luke's Hospital Bradford United Kingdom Recruiting
University Hospitals Sussex Brighton United Kingdom Recruiting
Kent and Canterbury Hospital Canterbury United Kingdom Recruiting
Hammersmith Hospital London United Kingdom Recruiting
Churchill Hospital Oxford United Kingdom Recruiting
Sheffield Kidney Institute Sheffield United Kingdom Recruiting

+ 1 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03994471 on ClinicalTrials.gov ↗ ← All trials in the UK