RecruitingPhase 2NCT04881682
Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Sponsor
University of Ulm
Enrollment
20 participants
Start Date
May 1, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria4
- 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
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Interventions
DEVICEImmunoadsorption
see arm/group description
BIOLOGICALImmunoglobulins
see arm/group description
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04881682
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