AzTrials
AzTrials

End Stage Renal DiseasePhase 3ELIXIRNCT03994471

Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.

A Phase 3 study testing XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght and 1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution in people with End Stage Renal Disease, run by Iperboreal Pharma Srl at 41 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End Stage Renal Disease
What is being tested?
XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght and 1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
41 sitesin 6 countries
Study dates
14 Dec 2022to 28 Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years
  • Diagnosed with ESRD and treated with CAPD in the last 3 months
  • In stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalization and major cardiovascular events
  • Have not experienced peritonitis episodes in the last 3 months
  • In treatment with prescribed Extraneal (nocturnal exchange bag solution) for at least 1 month
  • 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)
Show all 9Show fewer
  • Kt/V urea measurement > 1.7 per week at Baseline Visit
  • Followed/treated by the participating clinical Center/Investigator in the last three months
  • Understanding the nature of the study and providing their informed consent to participation.

Who cannot join

  • History of drug or alcohol abuse in the six months prior to entering the protocol
  • In treatment with androgens
  • Clinically significant abnormal liver function test (ɣ-GT > 4 times the upper normal limit)
  • Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)
  • Expected patient's survival shorter than the trial duration
  • History of L-Carnitine therapy or use in the month prior to entering the protocol
Show all 17Show fewer
  • Have used any investigational drug in the 3 months prior to entering the protocol
  • Female patients who are pregnant or breast-feeding.
  • Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception
  • Patients affected by Primary Hyperoxaluria as per known medical therapy
  • Patients with serum levels of uric acid > 7.2 mg/dl (male and postmenopausal women) or > 6.0 mg/dl (premenopausal women)
  • Patients with a major cardiovascular event in the last 3 months
  • Patients with advanced cardiac failure (NYHA 4)
  • Hypersensitivity to any of the constituents of the study IMPs.
  • Any contraindication to the prescribed Peritoneal Dialysis solutions (for long-dwell and short-dwell exchange) as per each product SmPC.
  • Participants with medical history of oxalate or lactate abnormalities considered clinically significant by the investigator.
  • 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.

Trial locations and contacts

41 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Arduino Arduini, MD contact

+39.333.6409595

a.arduini@iperboreal.com

41 sites in 6 countries

Italy19 sites, 19 recruiting

  • Ospedale Madonna del Soccorso

    Ascoli Piceno

    Matthias Zeiler, MD

    Recruiting

  • Ospedale Santa Maria Annunziata

    Bagno a Ripoli

    Rossella Cannavò, MD

    Not yet recruiting

  • Azienda Universitaria Ospedaliera di Bari

    Bari

    Loreto Gesualdo, MD

    Recruiting

  • ASST Spedali Civili di Brescia

    Brescia

    Federico Alberici, MD

    Not yet recruiting

  • Ospedale SS. Annunziata

    Chieti

    Mario Bonomini, MD, mario.bonomini@unich.it

    Recruiting

  • IRCCS Policlinico San Martino

    Genova

    Francesca Cappadona, MD

    Not yet recruiting

  • Ospedale Civile San Salvatore

    L’Aquila

    Luca Piscitani, MD

    Recruiting

  • ASST Fatebenefratelli-Sacco -Ospedale Luigi Sacco

    Milan

    Maurizio Gallieni, MD

    Recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan

    Luca Nardelli, MD

    Not yet recruiting

  • Azienda Ospedaliera Universitaria di Modena

    Modena

    Gabriele Donati, MD

    Recruiting

  • AOU Università degli studi della Campania

    Naples

    Francesco Trepiccione, MD

    Recruiting

  • Università della Campania L.Vanvitelli

    Naples

    Silvio Borrelli, MD

    Recruiting

  • Azienda Ospedaliera di Padova

    Padova

    Anna Bass, MD

    Not yet recruiting

  • Ospedale AUSL "Guglielmo da Saliceto"

    Piacenza

    Roberto Scarpioni, MD

    Recruiting

  • Ospedale S.Eugenio

    Roma

    Roberto Palumbo, MD

    Not yet recruiting

  • Ospedale C. e G. Mazzoni

    San Benedetto del Tronto

    Matthias Zailer, MD

    Recruiting

  • Azienda Ospedaliera Terni

    Terni

    Luigi Vecchi, MD

    Recruiting

  • Ospedale San Giovanni Bosco

    Torino

    Dario Roccatello, MD

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata di Verona

    Verona

    Giovanni Gambaro, MD

    Recruiting

Other trials in Italy

Spain8 sites, 8 recruiting

  • University Hospital A Coruña Fundación Profesor Novoa Santos

    A Coruña

    Miguel Perez Fontan, MD

    Recruiting

  • Hospital U. Germans Trias i Pujol

    Badalona

    Marie Troya Saborido, MD

    Recruiting

  • Fundaciòn Puigvert

    Barcelona

    Maria Alba Herreros, MD

    Recruiting

  • Hospital Universitario Josep Trueta

    Girona

    Claudia Castillo Devia

    Recruiting

  • Fundacion Jimenez Diaz

    Madrid

    Catalina Cleary, MD

    Recruiting

  • Hospital Ramón y Cajal

    Madrid

    Haridian Sosa Barrios, MD

    Not yet recruiting

  • Hospital Universitario La Paz

    Madrid

    Maria Bajo, MD

    Recruiting

  • Hospital Universitario Central De Asturias

    Oviedo

    Marie Rodriguez Suarez, MD

    Recruiting

Other trials in Spain

United Kingdom8 sites, 8 recruiting

  • Heartlands Hospital

    Birmingham

    Jyoti Baharani, MD

    Recruiting

  • St Luke's Hospital

    Bradford

    Ahsan Syed, MD

    Recruiting

  • University Hospitals Sussex

    Brighton

    Sarah Lawman, MD

    Recruiting

  • Kent and Canterbury Hospital

    Canterbury

    Nilesh Kumar Shah, MD

    Recruiting

  • Hammersmith Hospital

    London

    Richard Corbett, MD

    Recruiting

  • Churchill Hospital

    Oxford

    Udaya Udayaraj, MD

    Recruiting

  • Sheffield Kidney Institute

    Sheffield

    Martin Wilkie, MD

    Recruiting

  • University Hospitals of North Midlands

    Stoke-on-Trent

    Mark Lambie, MD

    Recruiting

Other trials in United Kingdom

Denmark3 sites, 3 recruiting

  • Aalborg University

    Aalborg

    Hanna Sofia Svensson, MD

    Not yet recruiting

  • Aarhus University Hospital

    Aarhus

    Johan Povlsen, MD

    Recruiting

  • Zealand University Hospital

    Roskilde

    Kirstine Møller Gliese, MD

    Recruiting

Other trials in Denmark

Sweden2 sites, 2 recruiting

  • Halland County Hospital of Halmstad

    Halmstad

    Karl Bjurström, MD

    Recruiting

  • Karolinska University Hospital

    Stockholm

    Olof Heimbürger, MD

    Recruiting

Other trials in Sweden

Germany1 site, 1 recruiting

  • Dialysis Center DaVita

    Düsseldorf

    Thilo Krueger, MD

    Recruiting

Other trials in Germany

About this study

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

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.

Read the detailed description

Patients should be enrolled if they are receiving 1, 2 or 3 diurnal exchanges of one of the following PD solutions (standard treatment): Physioneal 35 or 40 (including Clear-Flex bag), Fixioneal 35 or 40, Dianeal or Dianeal Low Calcium (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.5%, 2.3%, 4.25% glucose) - and - one bag of Extraneal (7.5% Icodextrin) for the long-dwell exchange. Patients will be centrally randomized to the investigational product (XyloCore) or the glucose-only PD solution active comparator. Patients randomized to the control group will continue with their prescription of standard treatment with 1, 2 to 3 daily (short-dwell) exchanges of Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova or Equibalance PD solution. Patients randomized to XyloCore will receive XyloCore Low, Medium or High Strength according to the osmotic strength (glucose concentration) of their prerandomization prescribed PD solution. All patients will keep being prescribed Extraneal (7.5% Icodextrin) for the nocturnal (long-dwell) exchange. The osmotic strength and number of diurnal short dwell exchanges may be modified by the investigator as clinically required. PD prescriptions in both treatment arms should be tailored to reach the minimum target of a total Kt/V of > 1.7 per week throughout the study. A stratified randomization scheme will be employed to ensure balanced allocation across the two treatment groups of patients with diabetes and of patients treated with only 1 diurnal exchange. Randomization will be performed centrally via a web-based system according to a computer-generated randomization list. The study is open-label with blinded evaluator (primary endpoint), without blinding of patients or clinical staff.

Being tested
XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght, 1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution
Keywords
peritoneal dialysis, ESRD
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High StrenghtDrug

    Also called XyloCore 0.7 or 1.5 or 2.0

    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 SolutionDrug

    Also called Physioneal 40 or 35, Fixioneal 40 or 35, Dianeal, Balance, Bicavera, Bicanova, Equibalance

    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 groups in NCT03994471
Study groupRoleWhat they receive
XyloCore peritoneal dialysis solutionExperimentalPatients 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.
Receives: Drug: XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght
Glucose peritoneal dialysis solutionActive comparatorPatients 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.
Receives: Drug: 1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total weekly Kt/Vurea

    To measure solutes and calculate peritoneal and renal Kt/V (summing up to total Kt/V), dialysate outflow and urine covering 24 hours will be collected, the volumes will be determined, and a blood sample will be taken

    Measured: 24-week

Secondary outcomes (13)

  1. Changes in HbA1c (glycated haemoglobin)

    Change from baseline value

    Measured: 6 months

  2. Insulin

    Changes from the baseline value

    Measured: 6 months

  3. LDL cholesterol

    Changes from the baseline value

    Measured: 6 months

  4. HDL cholesterol

    Change from the baseline value

    Measured: 6 months

  5. Serum triglycerides

    Change from the baseline value

    Measured: 6 months

  6. Total cholesterol

    Changes from the baseline

    Measured: 6 months

  7. Hemoglobin

    Changes from the baseline value

    Measured: 6 months

  8. EPO requirements

    Change from the baseline

    Measured: 6 months

  9. Fatigue measured through a validated instrument

    Changes from the baseline

    Measured: 6 months

  10. Peritoneal ultrafiltration

    Changes from baseline

    Measured: 6 months

  11. Diuresis (or 24 hours urinary volume)

    Changes from baseline

    Measured: 6 months

  12. Residual renal function

    Changes from baseline - measured as the arithmetic mean of urinary urea and creatinine clearance

    Measured: 6 months

  13. Adverse Events

    Information about all adverse events, whether volunteered by the patient, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded and followed as appropriate.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2019
  2. Study start14 Dec 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion28 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomization will be performed centrally via a web-based system, with stratification according to the presence or absence of diabetes.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03994471
Sponsor's protocol ID
IP-001-18
Other IDs
2019-004183-21, 2019
Acronym
ELIXIR
Status last verified
Mar 2026
First submitted
19 Jun 2019
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bonomini M, Davies S, Kleophas W, Lambie M, Reboldi G, Liberato LD, Divino-Filho JC, Heimburger O, Ortiz A, Povlsen J, Iacobelli M, Prosdocimi T, Arduini A. Rationale and design of ELIXIR, a randomized, controlled trial to evaluate efficacy and safety of XyloCore, a glucose-sparing solution for peritoneal dialysis. Perit Dial Int. 2025 Jan;45(1):17-25. doi: 10.1177/08968608241274106. Epub 2024 Aug 28.

    PubMed 39205396

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght and 1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution in people with End Stage Renal Disease, run by Iperboreal Pharma Srl at 41 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Italy, Spain, United Kingdom, Denmark, Sweden and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Arduino Arduini, MD (+39.333.6409595, a.arduini@iperboreal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total weekly Kt/Vurea (time frame: 24-week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03994471, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in