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Comparative Clinical Performance of Dialyzers Applied During High Volume Online Haemodiafiltration

NCT04102280 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-12-02

No results posted yet for this study

Summary

The clinical investigation will be performed to generate clinical data on clearances and removal rates for ß2-microglobulin and other uremic toxins and on clinical adverse events of the modified polysulfone membrane to fulfil obligations to follow the FX P600 dialyzer in the market.

Conditions

Interventions

DEVICE

Dialyser

Three consecutive treatment weeks and one follow-up week per patient. Each treatment week includes three hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX P600 Fresenius Medical Care, comparator Xevonta Hi 15 (B. Braun) and comparator Elisio 150H (Nipro)

Sponsors & Collaborators

  • Institut Dr. Schauerte (IDS)

    collaborator UNKNOWN

  • Fresenius Medical Care Deutschland GmbH

    lead INDUSTRY

Principal Investigators

  • Götz Ehlerding, Dr med · Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-29
Primary Completion
2020-11-06
Completion
2021-05-26

Countries

  • Germany

Study Locations

More Related Trials

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 NCT04102280 on ClinicalTrials.gov