Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.
A Study to EvaLuate the EffIcacy and Safety of XyloCore, a Glucose SparIng ExpeRimental Solution, for Peritoneal Dialysis
Iperboreal Pharma Srl
170 participants
Dec 14, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- 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 Equibalance (1.25%, 2.3%, 4.5% glucose)
- 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.
Exclusion Criteria17
- 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 determined by the clinical judgment of the investigator.
Interventions
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
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.
Locations(41)
View Full Details on ClinicalTrials.gov
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NCT03994471