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 groups

Locations

Denmark

Aalborg University Aalborg Denmark

Aarhus University Hospital Aarhus Denmark

Zealand University Hospital Roskilde Denmark

Germany

Dialysis Center DaVita Düsseldorf Germany

Sponsors and collaborators

Iperboreal Pharma Srl

Lead sponsor

Source ClinicalTrials.gov