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Toxins Removal and Inflammatory State modulAtion During Online Hemodiafiltration: Comparison of Two Different Dialyzers

NCT04554498 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-03-17

No results posted yet for this study

Summary

The primary goal of the study is to evaluate in patients on three times a week on-line HDF the efficacy, in terms of toxin removal and modulation of the inflammatory state, of two different dialyzers: Helixone versus Asimmetric cellulose triacetate (ATA).

Conditions

Interventions

DEVICE

1) high flux hemodiafiltration thrice -weekly during a 24 month follow-up

1. the comparison of the effects of the two membranes on the serum levels of albumin, B2M, CRP, myoglobin, light chains, retinol binding protein, homocysteine, p-cresol, indoxyl sulfate, BPA, alpha-1-microglobulin (A1M), FGF23 (fibroblast growth factor 23), and inflammatory cytokines; 2. the evaluation of the changes induced by the two filters on lymphocyte subsets, monocyte activation and senescence, and apoptosis rate; 3. the definition of the impact of the two membranes on the accumulation of AGEs as an index of metabolic and oxidative stress, determined by a non-invasive method based on the measurement of skin autofluorescence through a dedicated device (AGE Reader, DiagnOptics Technologies BV, Groningen, Netherlands).

Sponsors & Collaborators

  • University of Bologna

    collaborator OTHER

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Gaetano La Manna, Prof · StOrsola University Hospital, Bologna, Italy

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-05-01
Completion
2024-05-01

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 NCT04554498 on ClinicalTrials.gov