Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
ConditionCIDP
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Ulm
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Immunoadsorption
- Immunoglobulins
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Ulm
Lead sponsor
Miltenyi Biomedicine GmbH
Collaborator
Source ClinicalTrials.gov