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 participate
Age range18 Years
SexALL
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Inclusion criteria
β. Age β₯18 years
β. Diagnosed with ESRD and treated with CAPD in the last 3 months
β. In stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalization and major cardiovascular events
β. Have not experienced peritonitis episodes in the last 3 months
β. In treatment with prescribed Extraneal (nocturnal exchange bag solution) for at least 1 month
β. 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)
β. Kt/V urea measurement \> 1.7 per week at Baseline Visit
β. Followed/treated by the participating clinical Center/Investigator in the last three months
Exclusion criteria
β. History of drug or alcohol abuse in the six months prior to entering the protocol
β. In treatment with androgens
β. Clinically significant abnormal liver function test (Ι£-GT \> 4 times the upper normal limit)
β. Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)