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

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: Recruiting
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Drug: XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght; Drug: 1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution

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: Interventional
• Enrollment (Estimated): 170
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Arduino Arduini, MD; Phone Number: +39.333.6409595; Email: a.arduini@iperboreal.com

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
    • Recruiting
    • Ospedale SS. Annunziata
    • Contact: Mario Bonomini, MD; Email: mario.bonomini@unich.it
  • 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	24-week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in HbA1c (glycated haemoglobin)	Change from baseline value	6 months
Insulin	Changes from the baseline value	6 months
LDL cholesterol	Changes from the baseline value	6 months
HDL cholesterol	Change from the baseline value	6 months
Serum triglycerides	Change from the baseline value	6 months
Total cholesterol	Changes from the baseline	6 months
Hemoglobin	Changes from the baseline value	6 months
EPO requirements	Change from the baseline	6 months
Fatigue measured through a validated instrument	Changes from the baseline	6 months
Peritoneal ultrafiltration	Changes from baseline	6 months
Diuresis (or 24 hours urinary volume)	Changes from baseline	6 months
Residual renal function	Changes from baseline - measured as the arithmetic mean of urinary urea and creatinine clearance	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: Iperboreal Pharma Srl
• Investigators: Study Director: Arduino Arduini, MD, Iperboreal Pharma; Study Chair: Werner Kleophas, MD, DaVita Deutschland AG

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 28, 2027

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ESRD; peritoneal dialysis
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic; Physioneal 40
• Other Study ID 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