Immunoadsorption treatment for chronic inflammatory demyelinating polyneuropathy
Immunoadsorption for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
University of Ulm · NCT07154524
This observational study will try immunoadsorption as a next-step treatment for adults with CIDP who do not respond well to IVIg or methylprednisolone.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Ulm (other) |
| Locations | 1 site (Ulm, Baden-Wurttemberg) |
| Trial ID | NCT07154524 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, observational exploration enrolling about 140 adults with CIDP within the German Kompetenznetz Peripherer Nerv (KKPNS). Participants who are on or starting IVIg or methylprednisolone may be switched to immunoadsorption (IA) during an 18-month observation period if their response is insufficient. IA will be used as escalation therapy according to each center's therapeutic scheme, with a non-mandatory recommendation on session number, volumes, and frequency. Six-month follow-up visits and clinical outcome tracking will be used to collect safety and effectiveness information.
Who should consider this trial
Good fit: Adults (age ≥18) with CIDP diagnosed per EAN/PNS criteria who are currently receiving or starting treatment with IVIg or methylprednisolone are eligible.
Not a fit: Patients who already have an adequate clinical response to IVIg or methylprednisolone are unlikely to benefit from switching to IA.
Why it matters
Potential benefit: If successful, IA could offer better symptom control for patients who do not respond to IVIg or methylprednisolone, with fewer complications than conventional plasma exchange.
How similar studies have performed: Previous case series and nonrandomized reports suggest IA can be effective and better tolerated than plasma exchange, but randomized controlled evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of CIDP based on the EAN/PNS Guidelines on Diagnosis and Treatment of CIDP13 * age ≥ 18 years * Willing and capable of giving written informed consent * Currently receiving IVIg or MP treatment OR starting IVIg or MP treatment at baseline Exclusion Criteria: * none
Where this trial is running
Ulm, Baden-Wurttemberg
- University of Ulm — Ulm, Baden-Wurttemberg, Germany (RECRUITING)
Study contacts
- Principal investigator: Johannes Dorst — University of Ulm
- Study coordinator: Johannes Dorst, Prof. Dr.
- Email: johannes.dorst@uni-ulm.de
- Phone: +497311775285
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy, Immunoadsorption, Long-term effects, therapy-refractory