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ID06382675

Evaluation of the Plasma Filter PX2 with multiFiltrate Devices in Therapeutic Plasma Exchange for Autoimmune Diseases

Led by Fresenius Medical Care Deutschland GmbH · Updated on 2026-06-24

46

Participants Needed

7

Research Sites

12 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to collect treatment data on the new Plasma Filter PX2 used in therapeutic plasma exchange TPE for patients with autoimmune diseases. The study evaluates the plasma filters performance when combined with the multiFiltrate and multiFiltratePRO devices during TPE treatments. The single-group design reflects everyday clinical practice and seeks to contribute empirical evidence on the devices use without altering patients treatment plans. Participants will receive TPE treatments using the investigational Plasma Filter PX2 alongside the multiFiltrate or multiFiltratePRO devices. Treatments are conducted according to clinical standards established at each center and prescribed by the treating physician. The study does not define a fixed treatment schedule and includes documentation of up to ten TPE treatments per participant. During the study, researchers will collect detailed information about the TPE treatments, including therapy parameters over an average period of about seven weeks depending on individual indications and treatment frequency. Participants will be monitored for treatment data collection, and safety assessments like pregnancy testing will be conducted as needed. The studys total duration spans from treatment documentation through to study completion, supporting a comprehensive evaluation of the Plasma Filter PX2.

CONDITIONS

Brief Title

Clinical Performance of the New Plasma Filter PX2 in TPE Treatments

Research Team

M

Manuela Stauss-Grabo, Dr.

J

Jana Schmitt

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