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Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.

NCT03994471 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2026-03-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght

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

DRUG

1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution

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.

Sponsors & Collaborators

  • Iperboreal Pharma Srl

    lead INDUSTRY

Principal Investigators

  • Arduino Arduini, MD · Iperboreal Pharma

  • Werner Kleophas, MD · DaVita Deutschland AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-14
Primary Completion
2026-12-31
Completion
2027-04-28

Countries

  • Denmark
  • Germany
  • Italy
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03994471 on ClinicalTrials.gov