NCT04881682 Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
| NCT ID | NCT04881682 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Ulm |
| Condition | CIDP |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2023-05-01 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Criteria: * 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 Criteria: * 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
Contact & Investigator
Johannes Dorst, Prof
PRINCIPAL INVESTIGATOR
University of Ulm
Frequently Asked Questions
Who can join the NCT04881682 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CIDP. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04881682 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04881682 currently recruiting?
Yes, NCT04881682 is actively recruiting participants. Contact the research team at johannes.dorst@uni-ulm.de for enrollment information.
Where is the NCT04881682 trial being conducted?
This trial is being conducted at Ulm, Germany.
Who is sponsoring the NCT04881682 clinical trial?
NCT04881682 is sponsored by University of Ulm. The principal investigator is Johannes Dorst, Prof at University of Ulm. The trial plans to enroll 20 participants.