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REmoval of Free Light Chains. A COmpaRison of Three Different dialyzERs

NCT02950389 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-03-18

No results posted yet for this study

Summary

Immunoglobulin light chains are classified as middle molecule uremic toxins able to interact with B lymphocyte membranes leading to the activation of transmembrane signaling. The ensuing impairment of neutrophil function can contribute to the chronic inflammation state of uremic patients, and the increased risk of bacterial infections or vascular calcifications. The aim of this crossover observational study was to assess the difference in free light chain removal by three different hemodialysis filters in patients not affected by multiple myeloma.

Free light chain removal was compared in the polymethylmethacrylate (PMMA) membrane Filtryzer BK-F, the polyphenylene HFR17 filter and the conventional polysulfone filter F7 High Performance dialysers (HPS). Twenty chronic hemodialysis patients were enrolled. The patients were randomized into two groups of treatment lasting six weeks each. The dialysis sessions checked were the midweek sessions and the blood was drawn at times 0, 120' and 240'. Kappa (k) and lambda (l) light chain levels, beta2microglobulin (β2M), C reactive protein (CRP) and albumin were checked.

Conditions

  • Complication of Hemodialysis

Interventions

DEVICE

PMMA filter

DEVICE

HFR17 filter

DEVICE

F7 filter

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Gabriele Donati, MD, PhD · S.Orsola University Hospital, Nephrology Dialysis and Renal Transplantation Unit

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Italy

Study Locations

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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 NCT02950389 on ClinicalTrials.gov