Status:
RECRUITING
Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Lead Sponsor:
University of Ulm
Collaborating Sponsors:
Miltenyi Biomedicine GmbH
Conditions:
CIDP
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Criteria
Inclusion
- 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
Exclusion
- Clinical or laboratory evidence of manifest systemic infection, i.e., C-reactive protein (CRP) above 20 mg/l, or evidence of nitrite-positive urinary tract infection
- Intake of angiotensin converting enzyme inhibitor within 1 week before first treatment
- immunoglobulin A deficiency
- Other contraindications against immunoadsorption or intravenous immunoglobulins
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04881682
Start Date
May 1 2023
End Date
March 1 2026
Last Update
December 5 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Neurology, University of Ulm
Ulm, Baden-Wurttemberg, Germany, 89081