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Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol, and L-Carnitine in CAPD

NCT04001036 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-03-03

No results posted yet for this study

Summary

Prospective, randomized, controlled clinical trial. The aim is to compare the effects of the peritoneal dialysis solution IPX15, containing glucose (0.5%), xylitol (1.5%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 2.5% glucose PD solution), for the nocturnal exchange with the PD solution IPX07, containing glucose (0.5%), xylitol (0.7%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 1.5% glucose PD solution), for the diurnal (short dwell) exchanges. Planned total recruitment is 40 patients with stable end-stage renal disease (ESRD) treated by continuous ambulatory peritoneal dialysis (CAPD). Treatment duration will be 4 weeks plus a 4 weeks safety follow up with no treatment.

Conditions

Interventions

DRUG

1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine

One bag for nocturnal (long-dwell) exchange.

DRUG

0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine

One to three, daily (short-dwell) exchanges

Sponsors & Collaborators

  • Iperboreal Pharma Srl

    lead INDUSTRY

Principal Investigators

  • Mario Bonomini, MD · Institute of Nephrology, G. D'annunzio University, Chieti, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2022-08-30
Completion
2022-08-30

Countries

  • Italy

Study Locations

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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 NCT04001036 on ClinicalTrials.gov