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Clearum High Flux Hemodialyzer Used in Hemodialysis for Subjects With End-Stage Renal Disease

NCT04395131 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-01

No results posted yet for this study

Summary

The study will be a prospective, interventional, non-randomized, single-center study in 20 ESRD patients on hemodialysis. The study will compare performance of the Clearum HS dialyzer to typical values obtained with other commercially available high flux dialyzers. In addition, the Clearum HS dialyzer will be compared to a Fresenius FX80 dialyzer for a baseline (control) comparison. This will be a post-market study. The duration of the trial is 2 weeks for the FX80 control dialyzer + 6 weeks with the Clearum HS dialyzer used for 3x weekly high flux hemodialysis.

Conditions

  • End-stage Renal Disease

Interventions

DEVICE

Clearum HF Hemodialyzer

the hemodialyzer will be used 3x week for 3.5-4.5 hours with a Qb of at least 350 ml/min

Sponsors & Collaborators

  • Mozarc Medical US LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-03
Primary Completion
2020-08-14
Completion
2020-08-14

Countries

  • Germany

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 NCT04395131 on ClinicalTrials.gov