Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Who is this study for? Patients with Chronic Inflammatory Demyelinating Polyneuropathy
Status: Recruiting
Location: See location...
Intervention Type: Biological, Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a randomized controlled study evaluating safety and efficacy of repeated immunoadsorption versus immunoglobulins in steroid-refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Diagnosis of possible, probable, or definite CIDP (typical or atypical) according to European Federation of Neurological Societies (EFNS) guidelines
• Disease duration of 3 years or less
• Age 18 years or above
• Previous treatment with methyl-prednisolone and insufficient therapeutic response as judged by the treating physician, or contraindications against methyl-prednisolone, or clinically significant side effects under methyl-prednisolone therapy as judged by the treating physician
Locations
Other Locations
Germany
Department of Neurology, University of Ulm
RECRUITING
Ulm
Contact Information
Primary
Johannes Dorst, Prof
johannes.dorst@uni-ulm.de
+49 731 177 5285
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 20
Treatments
Experimental: Immunoadsorption
3 cycles of immunoadsorption in week 1, 7, and 13 after randomization. One cycle consists of 5 sessions on 5 consecutive days with processing of the 2-fold plasma volume on the first day and the 2.5-fold plasma volume on consecutive days, using regenerative adsorbers (Therasorb, Miltenyi Biotec, Bergisch Gladbach)
Active_comparator: Immunoglobulins
5 cycles of intravenous immunoglobulins in week 1, 4, 7, 10, and 13 after randomization. The first cycle consists of 5 intravenous applications of immunoglobulins on 5 consecutive days in a dosage of 0.4 g per kg body weight per day. Subsequent cycles consist of 2 intravenous applications of immunoglobulins on 2 consecutive days in a dosage of 0.5 g per kg body weight per day.
Related Therapeutic Areas
Sponsors
Collaborators: Miltenyi Biomedicine GmbH
Leads: University of Ulm