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Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine

NCT04086212 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-10-01

No results posted yet for this study

Summary

Randomized, cross-over, controlled, open label study. The aim of this study is to demonstrate that glucose may completely be replaced by a combination of xylitol and carnitine in the bimodal PD solution for long dwell exchange.

Conditions

  • End Stage Renal Disease (ESRD)

Interventions

DRUG

Icodextrin, xylitol and carnitine solution for peritoneal dialysis

Patients will receive a long dwell exchange for three days.

DRUG

EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution

Patients will receive a long dwell exchange for three days.

Sponsors & Collaborators

  • Iperboreal Pharma Srl

    lead INDUSTRY

Principal Investigators

  • Mario Bonomini, MD · Institute of Nephrology, University of Chieti, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-02
Primary Completion
2022-12-31
Completion
2023-04-30

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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 NCT04086212 on ClinicalTrials.gov