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Looking for participantsPhase3

Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.

Sponsor: Iperboreal Pharma Srl

NCT ID: NCT03994471

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
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 (drug)
How long the study runs
Study runs about 52 months (dates as stated)
About the drug or intervention
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 · 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.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at how well a peritoneal dialysis fluid called XyloCore works and how safe it is for adults with end stage renal disease (when the kidneys have stopped working properly). It is sponsored by Iperboreal Pharma Srl. People who join must already be having peritoneal dialysis, which is a treatment that cleans the blood inside the tummy.

Who can take part

  • Adults aged 18 or over
  • Diagnosed with end stage renal disease and treated with a type of peritoneal dialysis called CAPD (continuous ambulatory peritoneal dialysis) in the last 3 months
  • In a stable condition for the 3 months before screening, with no unplanned hospital stays or major heart events
  • No episodes of peritonitis (an infection of the tummy lining) in the last 3 months
  • Using a dialysis fluid called Extraneal overnight for at least 1 month
  • Using 1, 2 or 3 daytime dialysis fluids such as Phisioneal, Fixioneal, Dianeal or Balance-type fluids
  • A weekly dialysis adequacy measurement (Kt/V urea) above 1.7 at the start of the study
  • Been cared for by the study centre or doctor for the last 3 months
  • Understand the study and agree to take part

Who may not be able to

  • Drug or alcohol misuse in the last 6 months
  • Taking androgen medicines
  • Liver blood tests much higher than normal (ɣ-GT more than 4 times the normal limit)
  • An acute infection, such as a chest infection, hepatitis or a urine infection
  • Not expected to live for the whole length of the trial
  • Used L-Carnitine therapy in the last month
  • Taken any investigational (experimental) drug in the last 3 months
  • Pregnant or breastfeeding women
  • Women who can have children and do not use adequate contraception
  • People with a condition called primary hyperoxaluria
  • Uric acid levels in the blood that are too high
  • A major heart event in the last 3 months
  • Advanced heart failure (NYHA class 4, the most severe stage)
  • Allergy to any of the ingredients in the study fluids
  • Any reason the prescribed dialysis fluids would not be suitable
  • A history of oxalate or lactate problems the doctor considers important
  • Any other condition the doctor believes would put the person at risk or affect the study results

What taking part involves

  • • Not stated — ask the trial team. The study tests a peritoneal dialysis solution called XyloCore, but the exact tests and procedures are not described in the registry data.

Time commitment: Number of visits and total study length: Not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
170
Started
2022-12-14
Last checked
2026-03

Plain English Summary

What is this study?

  • • Testing a new treatment for end stage renal disease
  • • Phase3 - 170 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with end stage renal disease

Where?

  • • Birmingham - Heartlands Hospital
  • • Bradford - St Luke's Hospital
  • • Brighton - University Hospitals Sussex
  • • Canterbury - Kent and Canterbury Hospital
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

End Stage Renal Disease

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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...
  • ✓Have not experienced peritonitis episodes in the last 3 months
  • ✓In treatment with prescribed Extraneal (nocturnal exchange bag solution) for at least 1 month

Who cannot take part

  • ✗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.: lung infection, acute hepatitis, high or low urinary tract infections, kidney...
  • ✗Expected patient's survival shorter than the trial duration
See the full criteria
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.

Where Is This Study? (8 UK sites)

Heartlands Hospital

Birmingham, United Kingdom

Recruiting

St Luke's Hospital

Bradford, United Kingdom

Recruiting

University Hospitals Sussex

Brighton, United Kingdom

Recruiting
Hospital R&D contact (matched)

Scott Harfield

uhsussex.research@nhs.net01273 696955 ext. 67497

Kent and Canterbury Hospital

Canterbury, United Kingdom

Recruiting
Hospital R&D contact (matched)

Caroline Cowley, Research & Innovation/Clinical Trials Unit Manager

ekhuft.researchandinnovation@nhs.net01227 783169

Hammersmith Hospital

London, United Kingdom

Recruiting

Churchill Hospital

Oxford, United Kingdom

Recruiting

Sheffield Kidney Institute

Sheffield, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

University Hospitals of North Midlands

Stoke-on-Trent, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Jones

studysetup@uhnm.nhs.uk01782 675385

How to Get in Touch

Arduino Arduini, MD

Sponsor contact

CONTACT

+39.333.6409595 a.arduini@iperboreal.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-03