Actively Recruiting
Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.
Led by Iperboreal Pharma Srl · Updated on 2026-03-24
170
Participants Needed
41
Research Sites
228 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with End-Stage Renal Disease (ESRD) and treated with Continuous Ambulatory Peritoneal Dialysis (CAPD) for at least 3 months
- Stable clinical condition during the past 3 months with no non-elective hospitalizations or major cardiovascular events
- No peritonitis episodes in the last 3 months
- Receiving Extraneal (7.5% Icodextrin) for nocturnal exchange for at least 1 month
- Using 1, 2, or 3 daily exchanges of glucose-based PD solutions such as Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova, or Equibalance
- Baseline Kt/V urea measurement greater than 1.7 per week
- Followed or treated by the participating clinical center or investigator in the last 3 months
- Understands the study and provides informed consent
You will not qualify if you...
- History of drug or alcohol abuse within the past 6 months
- Currently treated with androgens
- Significant liver function abnormalities (γ-GT more than 4 times the upper normal limit)
- Acute infections such as pulmonary or urinary tract infections
- Expected survival shorter than the trial duration
- Prior L-Carnitine therapy or use within 1 month before the study
- Use of investigational drugs within 3 months before the study
- Pregnancy or breastfeeding in female patients
- Female patients of childbearing potential not using adequate contraception
- Diagnosis of Primary Hyperoxaluria
- Elevated serum uric acid levels above specified thresholds
- Major cardiovascular event within the last 3 months
- Advanced heart failure (NYHA class 4)
- Allergic reaction to study treatments
- Contraindications to prescribed peritoneal dialysis solutions
- Medical history of oxalate or lactate abnormalities considered significant
- Any other medical, neurological, or psychological conditions posing undue risk or interfering with study assessments as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 41 locations
1
Aalborg University
Aalborg, Denmark
Not Yet Recruiting
2
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
3
Zealand University Hospital
Roskilde, Denmark
Actively Recruiting
4
Dialysis Center DaVita
Düsseldorf, Germany
Actively Recruiting
5
Ospedale Madonna del Soccorso
Ascoli Piceno, Italy
Actively Recruiting
6
Ospedale Santa Maria Annunziata
Bagno a Ripoli, Italy
Not Yet Recruiting
7
Azienda Universitaria Ospedaliera di Bari
Bari, Italy
Actively Recruiting
8
ASST Spedali Civili di Brescia
Brescia, Italy
Not Yet Recruiting
9
Ospedale SS. Annunziata
Chieti, Italy
Actively Recruiting
10
IRCCS Policlinico San Martino
Genova, Italy
Not Yet Recruiting
11
Ospedale Civile San Salvatore
L’Aquila, Italy
Actively Recruiting
12
ASST Fatebenefratelli-Sacco -Ospedale Luigi Sacco
Milan, Italy
Actively Recruiting
13
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Not Yet Recruiting
14
Azienda Ospedaliera Universitaria di Modena
Modena, Italy
Actively Recruiting
15
AOU Università degli studi della Campania
Naples, Italy
Actively Recruiting
16
Università della Campania L.Vanvitelli
Naples, Italy
Actively Recruiting
17
Azienda Ospedaliera di Padova
Padova, Italy
Not Yet Recruiting
18
Ospedale AUSL "Guglielmo da Saliceto"
Piacenza, Italy
Actively Recruiting
19
Ospedale S.Eugenio
Roma, Italy
Not Yet Recruiting
20
Ospedale C. e G. Mazzoni
San Benedetto del Tronto, Italy
Actively Recruiting
21
Azienda Ospedaliera Terni
Terni, Italy
Actively Recruiting
22
Ospedale San Giovanni Bosco
Torino, Italy
Actively Recruiting
23
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, Italy
Actively Recruiting
24
University Hospital A Coruña Fundación Profesor Novoa Santos
A Coruña, Spain
Actively Recruiting
25
Hospital U. Germans Trias i Pujol
Badalona, Spain
Actively Recruiting
26
Fundaciòn Puigvert
Barcelona, Spain
Actively Recruiting
27
Hospital Universitario Josep Trueta
Girona, Spain
Actively Recruiting
28
Fundacion Jimenez Diaz
Madrid, Spain
Actively Recruiting
29
Hospital Ramón y Cajal
Madrid, Spain
Not Yet Recruiting
30
Hospital Universitario La Paz
Madrid, Spain
Actively Recruiting
31
Hospital Universitario Central De Asturias
Oviedo, Spain
Actively Recruiting
32
Halland County Hospital of Halmstad
Halmstad, Sweden
Actively Recruiting
33
Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
34
Heartlands Hospital
Birmingham, United Kingdom
Actively Recruiting
35
St Luke's Hospital
Bradford, United Kingdom
Actively Recruiting
36
University Hospitals Sussex
Brighton, United Kingdom
Actively Recruiting
37
Kent and Canterbury Hospital
Canterbury, United Kingdom
Actively Recruiting
38
Hammersmith Hospital
London, United Kingdom
Actively Recruiting
39
Churchill Hospital
Oxford, United Kingdom
Actively Recruiting
40
Sheffield Kidney Institute
Sheffield, United Kingdom
Actively Recruiting
41
University Hospitals of North Midlands
Stoke-on-Trent, United Kingdom
Actively Recruiting
Research Team
A
Arduino Arduini, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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