BridgeMD
A Study to Evaluate the Efficacy and Safety of XyloCore, a Glucose Sparing Experimental Solution, for Peritoneal Dialysis (ELIXIR)
EU CTIS ID: 2024-513562-19-00
What this study is testing
To demonstrate the non-inferiority of XyloCore compared to the standard treatment of glucose PD solutions, with regards to the weekly Kt/V urea
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years
- Diagnosis of 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 hospitalisation and major cardiovascular events
- Have not experienced peritonitis episodes in the last 3 months
- In treatment with Extraneal (nocturnal long-dwell exchange for at least one month)
- In treatment with 1, 2 or 3 short-dwell prescribed exchanges with Physioneal (including Clear-Flex bag), Fixioneal, Dianeal or Dianeal Low Calcium (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.5%, 2.3%, 4.25% glucose)
You likely can't join if
- History of drug or alcohol abuse in the six months prior to entering the protocol
- Patients affected by Primary Hyperoxaluria as per known medical history
- Patients affected by gout, who have had one or more flares of gout during the last 12 months before the screening, 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
See the full eligibility criteria
- Age ≥18 years
- Diagnosis of 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 hospitalisation and major cardiovascular events
- Have not experienced peritonitis episodes in the last 3 months
- In treatment with Extraneal (nocturnal long-dwell exchange for at least one month)
- In treatment with 1, 2 or 3 short-dwell prescribed exchanges with Physioneal (including Clear-Flex bag), Fixioneal, Dianeal or Dianeal Low Calcium (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.5%, 2.3%, 4.25% glucose)
- Weekly Kt/V urea measurement > 1.7
- Followed-up/treated by the participating clinical Center/Investigator in the last three months
- Understanding the nature of the study and providing informed consent to participate in the study
- History of drug or alcohol abuse in the six months prior to entering the protocol
- Patients affected by Primary Hyperoxaluria as per known medical history
- Patients affected by gout, who have had one or more flares of gout during the last 12 months before the screening, 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
- Participants with medical history of oxalate or lactate abnormalities considered clinically significant by the investigator
- 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
- In treatment with androgens
- Clinically significant abnormal liver function test (Gamma-GT and/or AST and/or ALT > 2 UNL; and/or total bilirubin > 3 UNL)
- Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low tract urinary infections, renal parenchymal infection, pericarditis, etc)
- Expected patient’s survival shorter than trial duration
- L-Carnitine therapy 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
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.