Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.

NCT03994471 | Recruiting Phase 3

• 2 other identifiers: IP-001-182019-004183-21
• Study Type: interventional
• Target: 170
• Locations: 6 countries
• Sites: 41

Brief 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 Renal Disease (ESRD) receiving Continuous Ambulatory Peritoneal Dialysis (CAPD), over a 6-month study period.

Conditions

End Stage Renal Disease

Keywords

peritoneal dialysis; ESRD

Outcome Measures

Primary Outcomes (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

  24-week

Secondary Outcomes (13)

• Changes in HbA1c (glycated haemoglobin)

  6 months

• Insulin

  6 months

• LDL cholesterol

  6 months

• HDL cholesterol

  6 months

• Serum triglycerides

  6 months

Study Arms (2)

XyloCore peritoneal dialysis solution

EXPERIMENTAL

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

Glucose peritoneal dialysis solution

ACTIVE COMPARATOR

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

Interventions

XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght DRUG

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

Also known as: XyloCore 0.7 or 1.5 or 2.0

XyloCore peritoneal dialysis solution

1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution DRUG

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.

Also known as: Physioneal 40 or 35, Fixioneal 40 or 35, Dianeal, Balance, Bicavera, Bicanova, Equibalance

Glucose peritoneal dialysis solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Iperboreal Pharma Srl: lead

Study Sites (41)

Aalborg University

Aalborg, Denmark

NOT YET RECRUITING

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Zealand University Hospital

Roskilde, Denmark

RECRUITING

Dialysis Center DaVita

Düsseldorf, Germany

RECRUITING

Ospedale Madonna del Soccorso

Ascoli Piceno, Italy

RECRUITING

Ospedale Santa Maria Annunziata

Bagno a Ripoli, Italy

NOT YET RECRUITING

Azienda Universitaria Ospedaliera di Bari

Bari, Italy

RECRUITING

ASST Spedali Civili di Brescia

Brescia, Italy

NOT YET RECRUITING

Ospedale SS. Annunziata

Chieti, Italy

RECRUITING

IRCCS Policlinico San Martino

Genova, Italy

NOT YET RECRUITING

Ospedale Civile San Salvatore

L’Aquila, Italy

RECRUITING

ASST Fatebenefratelli-Sacco -Ospedale Luigi Sacco

Milan, Italy

RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria di Modena

Modena, Italy

RECRUITING

AOU Università degli studi della Campania

Naples, Italy

RECRUITING

Università della Campania L.Vanvitelli

Naples, Italy

RECRUITING

Azienda Ospedaliera di Padova

Padua, Italy

NOT YET RECRUITING

Ospedale AUSL "Guglielmo da Saliceto"

Piacenza, Italy

RECRUITING

Ospedale S.Eugenio

Roma, Italy

NOT YET RECRUITING

Ospedale C. e G. Mazzoni

San Benedetto del Tronto, Italy

RECRUITING

Azienda Ospedaliera Terni

Terni, Italy

RECRUITING

Ospedale San Giovanni Bosco

Torino, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, Italy

RECRUITING

University Hospital A Coruña Fundación Profesor Novoa Santos

A Coruña, Spain

RECRUITING

Hospital U. Germans Trias i Pujol

Badalona, Spain

RECRUITING

Fundaciòn Puigvert

Barcelona, Spain

RECRUITING

Hospital Universitario Josep Trueta

Girona, Spain

RECRUITING

Fundacion Jimenez Diaz

Madrid, Spain

RECRUITING

Hospital Ramón y Cajal

Madrid, Spain

NOT YET RECRUITING

Hospital Universitario La Paz

Madrid, Spain

RECRUITING

Hospital Universitario Central De Asturias

Oviedo, Spain

RECRUITING

Halland County Hospital of Halmstad

Halmstad, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Heartlands Hospital

Birmingham, United Kingdom

RECRUITING

St Luke's Hospital

Bradford, United Kingdom

RECRUITING

University Hospitals Sussex

Brighton, United Kingdom

RECRUITING

Kent and Canterbury Hospital

Canterbury, United Kingdom

RECRUITING

Hammersmith Hospital

London, United Kingdom

RECRUITING

Churchill Hospital

Oxford, United Kingdom

RECRUITING

Sheffield Kidney Institute

Sheffield, United Kingdom

RECRUITING

University Hospitals of North Midlands

Stoke-on-Trent, United Kingdom

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Physioneal 40

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arduino Arduini, MD

  Iperboreal Pharma

  STUDY DIRECTOR

• Werner Kleophas, MD

  DaVita Deutschland AG

  STUDY CHAIR

Central Study Contacts

Arduino Arduini, MD

CONTACT

+39.333.6409595; a.arduini@iperboreal.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study cannot be blinded. The assessment of the primary end-point will be performed by a blinded, third party, independent assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization will be performed centrally via a web-based system, with stratification according to the presence or absence of diabetes.

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 21, 2019
• Study Start: December 14, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 28, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

DK (3); ES (8); SE (2); GB (8); IT (19); DE (1)