Efficacy and Safety of XyloCore Peritoneal Dialysis Solution. (ELIXIR)

March 23, 2026 updated by: Iperboreal Pharma Srl

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Not yet recruiting
        • Aalborg University
        • Contact:
          • Hanna Sofia Svensson, MD
      • Aarhus, Denmark
        • Recruiting
        • Aarhus University Hospital
        • Contact:
          • Johan Povlsen, MD
      • Roskilde, Denmark
        • Recruiting
        • Zealand University Hospital
        • Contact:
          • Kirstine Møller Gliese, MD
  • Germany
      • Düsseldorf, Germany
        • Recruiting
        • Dialysis Center DaVita
        • Contact:
          • Thilo Krueger, MD
  • Italy
      • Ascoli Piceno, Italy
        • Recruiting
        • Ospedale Madonna del Soccorso
        • Contact:
          • Matthias Zeiler, MD
      • Bagno a Ripoli, Italy
        • Not yet recruiting
        • Ospedale Santa Maria Annunziata
        • Contact:
          • Rossella Cannavò, MD
      • Bari, Italy
        • Recruiting
        • Azienda Universitaria Ospedaliera di Bari
        • Contact:
          • Loreto Gesualdo, MD
      • Brescia, Italy
        • Not yet recruiting
        • ASST Spedali Civili di Brescia
        • Contact:
          • Federico Alberici, MD
      • Chieti, Italy
      • Genova, Italy
        • Not yet recruiting
        • IRCCS Policlinico San Martino
        • Contact:
          • Francesca Cappadona, MD
      • L’Aquila, Italy
        • Recruiting
        • Ospedale Civile San Salvatore
        • Contact:
          • Luca Piscitani, MD
      • Milan, Italy
        • Not yet recruiting
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
        • Contact:
          • Luca Nardelli, MD
      • Milan, Italy
        • Recruiting
        • ASST Fatebenefratelli-Sacco -Ospedale Luigi Sacco
        • Contact:
          • Maurizio Gallieni, MD
      • Modena, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria di Modena
        • Contact:
          • Gabriele Donati, MD
      • Naples, Italy
        • Recruiting
        • AOU Università degli studi della Campania
        • Contact:
          • Francesco Trepiccione, MD
      • Naples, Italy
        • Recruiting
        • Università della Campania L.Vanvitelli
        • Contact:
          • Silvio Borrelli, MD
      • Padua, Italy
        • Not yet recruiting
        • Azienda Ospedaliera Di Padova
        • Contact:
          • Anna Bass, MD
      • Piacenza, Italy
        • Recruiting
        • Ospedale AUSL "Guglielmo da Saliceto"
        • Contact:
          • Roberto Scarpioni, MD
      • Roma, Italy
        • Not yet recruiting
        • Ospedale S.Eugenio
        • Contact:
          • Roberto Palumbo, MD
      • San Benedetto del Tronto, Italy
        • Recruiting
        • Ospedale C. e G. Mazzoni
        • Contact:
          • Matthias Zailer, MD
      • Terni, Italy
        • Recruiting
        • Azienda Ospedaliera Terni
        • Contact:
          • Luigi Vecchi, MD
      • Torino, Italy
        • Recruiting
        • Ospedale San Giovanni Bosco
        • Contact:
          • Dario Roccatello, MD
      • Verona, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata di Verona
        • Contact:
          • Giovanni Gambaro, MD
  • Spain
      • A Coruña, Spain
        • Recruiting
        • University Hospital A Coruña Fundación Profesor Novoa Santos
        • Contact:
          • Miguel Perez Fontan, MD
      • Badalona, Spain
        • Recruiting
        • Hospital U. Germans Trias i Pujol
        • Contact:
          • Marie Troya Saborido, MD
      • Barcelona, Spain
        • Recruiting
        • Fundaciòn Puigvert
        • Contact:
          • Maria Alba Herreros, MD
      • Girona, Spain
        • Recruiting
        • Hospital Universitario Josep Trueta
        • Contact:
          • Claudia Castillo Devia
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Maria Bajo, MD
      • Madrid, Spain
        • Recruiting
        • Fundacion Jimenez Diaz
        • Contact:
          • Catalina Cleary, MD
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Ramon y Cajal
        • Contact:
          • Haridian Sosa Barrios, MD
      • Oviedo, Spain
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
          • Marie Rodriguez Suarez, MD
  • Sweden
      • Halmstad, Sweden
        • Recruiting
        • Halland County Hospital of Halmstad
        • Contact:
          • Karl Bjurström, MD
      • Stockholm, Sweden
        • Recruiting
        • Karolinska University Hospital
        • Contact:
          • Olof Heimbürger, MD
  • United Kingdom
      • Birmingham, United Kingdom
        • Recruiting
        • Heartlands Hospital
        • Contact:
          • Jyoti Baharani, MD
      • Bradford, United Kingdom
        • Recruiting
        • St Luke's Hospital
        • Contact:
          • Ahsan Syed, MD
      • Brighton, United Kingdom
        • Recruiting
        • University Hospitals Sussex
        • Contact:
          • Sarah Lawman, MD
      • Canterbury, United Kingdom
        • Recruiting
        • Kent and Canterbury Hospital
        • Contact:
          • Nilesh Kumar Shah, MD
      • London, United Kingdom
        • Recruiting
        • Hammersmith Hospital
        • Contact:
          • Richard Corbett, MD
      • Oxford, United Kingdom
        • Recruiting
        • Churchill Hospital
        • Contact:
          • Udaya Udayaraj, MD
      • Sheffield, United Kingdom
        • Recruiting
        • Sheffield Kidney Institute
        • Contact:
          • Martin Wilkie, MD
      • Stoke-on-Trent, United Kingdom
        • Recruiting
        • University Hospitals of North Midlands
        • Contact:
          • Mark Lambie, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: 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
Other Names:
  • XyloCore 0.7 or 1.5 or 2.0
Active Comparator: 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.
Drug: 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 Names:
  • Physioneal 40 or 35, Fixioneal 40 or 35, Dianeal, Balance, Bicavera, Bicanova, Equibalance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total weekly Kt/Vurea
Time Frame: 24-week
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
24-week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in HbA1c (glycated haemoglobin)
Time Frame: 6 months
Change from baseline value
6 months
Insulin
Time Frame: 6 months
Changes from the baseline value
6 months
LDL cholesterol
Time Frame: 6 months
Changes from the baseline value
6 months
HDL cholesterol
Time Frame: 6 months
Change from the baseline value
6 months
Serum triglycerides
Time Frame: 6 months
Change from the baseline value
6 months
Total cholesterol
Time Frame: 6 months
Changes from the baseline
6 months
Hemoglobin
Time Frame: 6 months
Changes from the baseline value
6 months
EPO requirements
Time Frame: 6 months
Change from the baseline
6 months
Fatigue measured through a validated instrument
Time Frame: 6 months
Changes from the baseline
6 months
Peritoneal ultrafiltration
Time Frame: 6 months
Changes from baseline
6 months
Diuresis (or 24 hours urinary volume)
Time Frame: 6 months
Changes from baseline
6 months
Residual renal function
Time Frame: 6 months
Changes from baseline - measured as the arithmetic mean of urinary urea and creatinine clearance
6 months
Adverse Events
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Iperboreal Pharma Srl

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Arduino Arduini, MD, Iperboreal Pharma
  • Study Chair: Werner Kleophas, MD, DaVita Deutschland AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 14, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IP-001-18
  • 2019-004183-21 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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