BridgeMD
Tests treatment safety and results for End Stage Renal Disease
Official title Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.
ClinicalTrials.gov ID: NCT03994471
What this study is testing
What is XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght?
XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght is an investigational medicine, given as an once-daily, being studied as a potential treatment for end stage renal disease.
Also referred to as XyloCore 0.7 or 1.5 or 2.0.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Have not experienced peritonitis episodes in the last 3 months
- In treatment with prescribed Extraneal (nocturnal exchange bag solution) for at least 1 month
You likely can't join 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...
- Expected patient's survival shorter than the trial duration
- History of L-Carnitine therapy or use in the month prior to entering the protocol
See the full eligibility criteria
- 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...
- 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.
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Denmark
- Aarhus, Denmark
- Roskilde, Denmark
- Düsseldorf, Germany
- Ascoli Piceno, Italy
- Bagno a Ripoli, Italy
- Bari, Italy
- Brescia, Italy
- Chieti, Italy
- Genova, Italy
- L’Aquila, Italy
- Milan, Italy
- Modena, Italy
- Naples, Italy
- Padova, Italy
- Piacenza, Italy
- Roma, Italy
- San Benedetto del Tronto, Italy
- Terni, Italy
- Torino, Italy
+ 17 more site(s).
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Denmark; Aarhus, Denmark; Roskilde, Denmark; Düsseldorf, Germany; Ascoli Piceno, Italy; Bagno a Ripoli, Italy and 31 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.