Safety and efficacy of a new solution, XyloCore, for peritoneal dialysis
| ISRCTN | ISRCTN16169961 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16169961 |
| EudraCT/CTIS number | 2019-004183-21 |
| IRAS number | 1005365 |
| ClinicalTrials.gov number | NCT03994471 |
| Secondary identifying numbers | IP-001-18, IRAS 1005365, CPMS 44912 |
- Submission date
- 26/04/2022
- Registration date
- 28/04/2022
- Last edited
- 06/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Peritoneal dialysis is a treatment for kidney failure that uses the lining of the abdomen (peritoneum) to filter the blood inside the body. XyloCore is a new solution for peritoneal dialysis. Current commercial peritoneal dialysis solutions have a high glucose content that could alter the function of the peritoneum and increase glycemia (blood glucose level) when administered for a long time. Xylocore solutions substitute a part of this glucose with other agents (xylitol and carnitine) to preserve the function of the peritoneum and glycemia in the long term while achieving similar effectiveness compared to current commercial solutions. Preliminary results of a clinical study (phase 2) on XyloCore showed improved effectiveness and fluid removal without relevant undesirable effects. Based on the promising results from phase 2, the current study is designed to investigate if XyloCore has similar effectiveness to the commercial products containing glucose.
Who can participate?
Patients aged 18 years and over with end-stage kidney disease and treated with peritoneal dialysis in the last 3 months
What does the study involve?
There are two treatment groups - XyloCore and standard of care peritoneal solution. Patients who are eligible to participate in the study will attend an initial visit to the clinic to confirm their eligibility and a second visit when they will start treatment with XyloCore or the standard of care solution. The duration of the treatment is 6 months and during this period they will have three clinic visits - at days 30, 120 and 180. During these clinic visits they will have blood tests, physical examinations, and assessments of their vital signs and kidney function. After the treatment period patients will be switched back to the standard of care treatment.
What are the possible benefits and risks of participating?
It has been observed that patients with a peritoneal catheter may have a risk of infections, namely peritonitis (inflammation of the peritoneum). In patients performing PD the risk of peritonitis is one episode over 3 years. Anyway more than 95% of PD-related peritonitis recovered by short-term treatment with antibiotics. The risk of peritonitis is also associated with insufficient training in PD bag correct use. The study team will train the patient to use the PD bag.
Where is the study run from?
Sintesi Research (Italy)
When is the study starting and how long is it expected to run for?
April 2022 to December 2025
Who is funding the study?
Iperboreal Pharma (Italy)
Who is the main contact?
Dr Mark Lambie
lambiem@doctors.org.uk
Contact information
Principal Investigator
Royal Stoke University Hospital
Newcastle Road
Stoke on Trent
ST4 6QG
United Kingdom
| Phone | +44 (0)1782 676346 |
|---|---|
| lambiem@doctors.org.uk |
Study information
| Study design | Open randomized controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A study to evaluate the efficacy and safety of XyloCore, a glucose-sparing experimental solution, for peritoneal dialysis |
| Study hypothesis | The primary objective of this study is to demonstrate the non-inferiority of XyloCore compared to the standard treatment of glucose PD solutions, with regards to the weekly Kt/Vurea. The study will also measure: 1. Changes from the baseline values of LDL, HDL and total cholesterol, serum triglycerides, HbA1c (glycated haemoglobin), and insulin 2. Changes from the baseline values of hemoglobin and EPO requirements (medication used to manage anemia in patients on dialysis) 3. Patients’ subjective assessment of fatigue (Chalder Fatigue Scale) 4. Peritoneal ultrafiltration 5. Diuresis (24 hours urinary volume) 6. Residual kidney function (measured as the arithmetic mean of urinary urea and creatinine clearance) |
| Ethics approval(s) | Approved 04/07/2022, East of England - Cambridgeshire and Hertfordshire Research Ethics Committee (Equinox House, City link, Nottingham, NG2 4LA, UK; Tel: not applicable; cambsandherts.rec@hra.nhs.uk), ref: 22/EE/0102 |
| Condition | Chronic kidney disease |
| Intervention | The purpose of the study is to evaluate if XyloCore, a new solution for peritoneal dialysis, is as safe as the commercially available solutions. There are two treatment groups: XyloCore and standard of care peritoneal solution. Patients who are eligible to participate in the study will attend an initial visit to the clinic to confirm their eligibility and a second visit when they will start treatment with XyloCore or the standard of care solution. The duration of the treatment is 6 months and during this period they will have three clinic visits at days 30, 120 and 180. During these clinic visits they will have blood tests, physical exams, and assessment of their vital signs and kidney function. After the treatment period patients will be switched back to the standard of care treatment. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Total weekly Kt/Vurea after a 24-week period using the assigned PD solution, assessed using a peritoneal function test. In brief, in order to measure solutes (urea) and calculate peritoneal and renal Kt/V (summing up to total Kt/V), blood, spent effluent (drained volume or dialysate outflow) and urine covering 24 hours will be collected. |
| Secondary outcome measures | 1. LDL, HDL and total cholesterol, serum triglycerides, HbA1c (glycated haemoglobin), and insulin measured using lab assessment at 6 months 2. Hemoglobin and EPO requirements measured using lab assessment at 6 months 3. Patients’ subjective assessment of fatigue using the Chalder Fatigue Scale at 6 months 4. Peritoneal ultrafiltration measured using lab assessment at 6 months 5. Diuresis (24 hours urinary volume) measured using lab assessment at 6 months 6. Residual kidney function, measured as the arithmetic mean of urinary urea and creatinine clearance at 6 months |
| Overall study start date | 22/04/2022 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 170 |
| Participant inclusion criteria | 1. Age ≥18 years 2. Diagnosed with end-stage renal disease (ESRD) and treated with continuous ambulatory peritoneal dialysis (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 long-dwell exchange) for at least 1 month 6. In treatment with 2 or 3 diurnal short-dwell prescribed exchanges with Physioneal (including Clear-Flex bag), Fixioneal, Dianeal, Dianeal low calcium (1.36%, 2.27% or 3.86% glucose), Balance, Bivavera, Bicanova or Equibalance (1.5%, 2.3%, 4.25% glucose) 7. Weekly Kt/V urea measurement ≥1.7 (See Annex 1) 8. Followed/treated by the participating clinical Center/Investigator in the last 3 months 9. Understanding the nature of the study and providing their informed consent to participate in the study |
| Participant exclusion criteria | 1. History of drug or alcohol abuse in the 6 months prior to entering the protocol 2. In treatment with androgens 3. Clinically significant abnormal liver function test (Gamma-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. L-Carnitine therapy 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 breastfeeding 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 history 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) |
| Recruitment start date | 30/10/2022 |
| Recruitment end date | 31/10/2023 |
Locations
Countries of recruitment
- Denmark
- England
- Germany
- Israel
- Italy
- Spain
- Sweden
- United Kingdom
Study participating centres
Stoke-on-Trent
ST4 6QG
United Kingdom
Bordesley Green
Birmingham
B9 5ST
United Kingdom
Hammersmith
London
W12 0HS
United Kingdom
Canterbury
CT1 3NG
United Kingdom
Bradford
BD5 0NA
United Kingdom
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
Herries Rd
Sheffield
S5 7AU
United Kingdom
Cardiff
CF14 4XN
United Kingdom
Derby
DE22 3NE
United Kingdom
Nottingham
NG5 1PB
United Kingdom
Brighton
BN2 5BE
United Kingdom
Sponsor information
Industry
Via S. Vittore 49
Milano
20123
Italy
| Phone | +39 (0)2 873 512 |
|---|---|
| t.prosdocimi@sintesiresearch.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | 1. Peer-reviewed scientific journals 2. Conference presentation 3. Submission to regulatory authorities 4. The data will be published in scientific journals |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
06/11/2024: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2024 to 31/12/2025.
2. The study participating centre Royal Berkshire Hospital was removed and Cardiff and Vale University Health Board, Royal Derby Hospital, Nottingham University Hospitals NHS Trust, University Hospitals Sussex NHS Foundation Trust were added.
26/10/2023: The overall end date was changed from 01/09/2024 to 31/12/2024.
14/11/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 30/09/2022 to 30/10/2022.
2. The recruitment end date was changed from 31/01/2023 to 31/10/2023.
08/11/2022: Ethics approval details added.
21/06/2022: The recruitment start date was changed from 01/05/2022 to 30/09/2022.
05/05/2022: Internal review.
26/04/2022: Trial's existence confirmed by the HRA.
