Actively Recruiting
Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Led by University of Ulm · Updated on 2026-05-01
20
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of Ulm
Lead Sponsor
M
Miltenyi Biomedicine GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of repeated immunoadsorption compared to immunoglobulin treatment in adults with steroid-refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This phase 2 randomized controlled trial focuses on patients with possible, probable, or definite CIDP, including both typical and atypical forms, who have not responded adequately to methyl-prednisolone treatment or cannot tolerate it. Participants are randomly assigned to receive either immunoadsorption or intravenous immunoglobulins. The immunoadsorption group undergoes three cycles in weeks 1, 7, and 13, each consisting of five consecutive daily sessions processing increasing plasma volumes using a specialized device. The immunoglobulin group receives five cycles at weeks 1, 4, 7, 10, and 13, starting with five daily intravenous applications at 0.4 g/kg followed by cycles of two consecutive days at 0.5 g/kg per day. Throughout the 15-week study period, participants will undergo multiple assessments including CIDP score, disability (INCAT) score, muscle strength (Oxford MRC), vibration score, pain evaluations, nerve conduction studies, and various immunological and inflammatory biomarkers. Researchers will monitor therapeutic response and quality of life at several time points, ensuring comprehensive evaluation of treatment effects and safety. The study is sponsored by the University of Ulm and is expected to complete by March 2028.
CONDITIONS
Brief Title
Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or contraindications or significant side effects as judged by the treating physician
You will not qualify if you...
- Clinical or laboratory evidence of manifest systemic infection, such as C-reactive protein above 20 mg/l or 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 13 weeks
Participants receive either immunoadsorption or intravenous immunoglobulins as treatment for CIDP. Immunoadsorption involves 3 cycles given in weeks 1, 7, and 13, each cycle consisting of 5 consecutive daily sessions. Immunoglobulin treatment involves 5 cycles in weeks 1, 4, 7, 10, and 13 with varying numbers of intravenous applications per cycle.
Multiple visits during treatment cycles across 13 weeks
Duration - Up to 3 weeks after treatment
Participants are monitored for treatment outcomes and safety through assessments up to week 16 after starting treatment.
Visits at weeks 15 and 16
Trial Site Locations
Total: 1 location
1
Department of Neurology, University of Ulm
Ulm, Baden-Wurttemberg, Germany, 89081
Actively Recruiting
Research Team
J
Johannes Dorst, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here