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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (8 UK sites)
Heartlands Hospital
Birmingham, United Kingdom
St Luke's Hospital
Bradford, United Kingdom
University Hospitals Sussex
Brighton, United Kingdom
Kent and Canterbury Hospital
Canterbury, United Kingdom
Caroline Cowley, Research & Innovation/Clinical Trials Unit Manager
ekhuft.researchandinnovation@nhs.net01227 783169Hammersmith Hospital
London, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Sheffield Kidney Institute
Sheffield, United Kingdom
University Hospitals of North Midlands
Stoke-on-Trent, United Kingdom
How to Get in Touch
Arduino Arduini, MD
Sponsor contactCONTACT
