Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.
ConditionEnd Stage Renal Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorIperboreal Pharma Srl
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght
- 1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution
Treatment groups
170 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov