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New dialysis fluid aims to cut sugar side effects

NCT ID NCT03994471

Disease control Sponsor: Iperboreal Pharma Srl Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests XyloCore, a dialysis solution with less glucose and added xylitol and L-carnitine, in 170 adults with end-stage kidney disease on continuous ambulatory peritoneal dialysis. The goal is to see if it can maintain dialysis effectiveness while improving metabolic health markers like blood sugar and cholesterol over 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XyloCore (a mix of xylitol, low glucose, and L-carnitine)
What this could lead to
If it works, this could offer a gentler dialysis option that reduces glucose-related side effects like high blood sugar and cholesterol.
What could go wrong
This is a mid-stage trial with only 170 participants, so results may not apply to everyone. The new solution might not work as well as standard glucose solutions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

End-stage renal disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    41 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Università degli studi della Campania

    RECRUITING

    Naples, Italy

  • ASST Fatebenefratelli-Sacco -Ospedale Luigi Sacco

    RECRUITING

    Milan, Italy

  • ASST Spedali Civili di Brescia

    NOT_YET_RECRUITING

    Brescia, Italy

  • Aalborg University

    NOT_YET_RECRUITING

    Aalborg, Denmark

  • Aarhus University Hospital

    RECRUITING

    Aarhus, Denmark

  • Azienda Ospedaliera Terni

    RECRUITING

    Terni, Italy

  • Azienda Ospedaliera Universitaria Integrata di Verona

    RECRUITING

    Verona, Italy

  • Azienda Ospedaliera Universitaria di Modena

    RECRUITING

    Modena, Italy

  • Azienda Ospedaliera di Padova

    NOT_YET_RECRUITING

    Padova, Italy

  • Azienda Universitaria Ospedaliera di Bari

    RECRUITING

    Bari, Italy

  • Churchill Hospital

    RECRUITING

    Oxford, United Kingdom

  • Dialysis Center DaVita

    RECRUITING

    Düsseldorf, Germany

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    NOT_YET_RECRUITING

    Milan, Italy

  • Fundacion Jimenez Diaz

    RECRUITING

    Madrid, Spain

  • Fundaciòn Puigvert

    RECRUITING

    Barcelona, Spain

  • Halland County Hospital of Halmstad

    RECRUITING

    Halmstad, Sweden

  • Hammersmith Hospital

    RECRUITING

    London, United Kingdom

  • Heartlands Hospital

    RECRUITING

    Birmingham, United Kingdom

  • Hospital Ramón y Cajal

    NOT_YET_RECRUITING

    Madrid, Spain

  • Hospital U. Germans Trias i Pujol

    RECRUITING

    Badalona, Spain

  • Hospital Universitario Central De Asturias

    RECRUITING

    Oviedo, Spain

  • Hospital Universitario Josep Trueta

    RECRUITING

    Girona, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, Spain

  • IRCCS Policlinico San Martino

    NOT_YET_RECRUITING

    Genova, Italy

  • Karolinska University Hospital

    RECRUITING

    Stockholm, Sweden

  • Kent and Canterbury Hospital

    RECRUITING

    Canterbury, United Kingdom

  • Ospedale AUSL "Guglielmo da Saliceto"

    RECRUITING

    Piacenza, Italy

  • Ospedale C. e G. Mazzoni

    RECRUITING

    San Benedetto del Tronto, Italy

  • Ospedale Civile San Salvatore

    RECRUITING

    L’Aquila, Italy

  • Ospedale Madonna del Soccorso

    RECRUITING

    Ascoli Piceno, Italy

  • Ospedale S.Eugenio

    NOT_YET_RECRUITING

    Roma, Italy

  • Ospedale SS. Annunziata

    RECRUITING

    Chieti, Italy

  • Ospedale San Giovanni Bosco

    RECRUITING

    Torino, Italy

  • Ospedale Santa Maria Annunziata

    NOT_YET_RECRUITING

    Bagno a Ripoli, Italy

  • Sheffield Kidney Institute

    RECRUITING

    Sheffield, United Kingdom

  • St Luke's Hospital

    RECRUITING

    Bradford, United Kingdom

  • University Hospital A Coruña Fundación Profesor Novoa Santos

    RECRUITING

    A Coruña, Spain

  • University Hospitals Sussex

    RECRUITING

    Brighton, United Kingdom

  • University Hospitals of North Midlands

    RECRUITING

    Stoke-on-Trent, United Kingdom

  • Università della Campania L.Vanvitelli

    RECRUITING

    Naples, Italy

  • Zealand University Hospital

    RECRUITING

    Roskilde, Denmark

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