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Exploratory Study to Explore the Safety and Efficacy of the HDx Therapy Using Theranova 500 Dialyzer in Comparison to Hemodiafiltration

NCT03499691 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-03-13

No results posted yet for this study

Summary

Today it is well established that middle molecules comprise several compounds that are not effectively removed by high-flux dialyzers, and effective clearance of large middle molecules in the process of dialysis depends on the dialyzer membrane having large enough pore sizes, larger than the conventional high-flux dialyzers. Studies have found associations between levels of large middle molecule uremic toxins and immune dysfunction and inflammation, as well as adverse outcomes. This indicates that dialysis membranes having larger pores, enabling an expanded HD (HDx) with more effective removal of large middle molecules, can have a positive impact on the inflammatory state. While data is starting to appear on the long-term use of the HDx therapy, little is still known on how large middle molecules and inflammation markers are affected over time.

Conditions

Interventions

DEVICE

Theranova 500 medium cut-off dialyzer

The patients randomized in this group using the Theranova 500 medium cut-off dialyzer, and blood flow rate and treatment duration will be maintained stable during the observation period. However, other prescriptions will vary based on the Principal Investigator's (PI's) judgment. If other dialyzers need to be temporarily used during the study period it shall be recorded which alternative dialyzers are used and for how long the study patient is on a different dialyzer. However, prior to Week 12 laboratory assessment it is recommended that the patient undergoes three dialysis sessions on the designated treatment mode.

DEVICE

Hemodiafiltration

The patients randomized in this group using the on-line high-flux HDF dialyzer, in post dilution mode, will continue to receive treatments according to their current treatment prescriptions for the duration of the study.

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Vantive Health LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-11
Primary Completion
2018-10-04
Completion
2018-10-04

Countries

  • Spain

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 NCT03499691 on ClinicalTrials.gov