Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght

    Drug

    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

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

    Drug

    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.

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: XyloCore peritoneal dialysis solutionExperimental treatment 1 intervention
Group B: Glucose peritoneal dialysis solutionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total weekly Kt/Vurea

To measure solutes and calculate peritoneal and renal Kt/V (summing up to total Kt/V), dialysate outflow and urine covering 24 hours will be collected, the volumes will be determined, and a blood sample will be taken

Time frame
24-week

Secondary outcomes

1

Changes in HbA1c (glycated haemoglobin)

Change from baseline value

Time frame
6 months
2

Insulin

Changes from the baseline value

Time frame
6 months
3

LDL cholesterol

Changes from the baseline value

Time frame
6 months
4

HDL cholesterol

Change from the baseline value

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Iperboreal Pharma Srl

Lead sponsor

Source ClinicalTrials.gov
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