Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
IVITOC
1 other identifier
interventional
20
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2023
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2021
CompletedFirst Posted
Study publicly available on registry
May 11, 2021
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
May 1, 2026
April 1, 2026
4.3 years
April 28, 2021
April 30, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
CIDP Score
The CIDP Score is a combined score of Inflammatory Cause and Treatment (INCAT) Disability Score, Oxford Muscle Strength Score, and Vibration Score, with each subscore equally weighted.
15 weeks
Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score
Standard clinical score for CIDP, quantifying disability.
15 weeks
Oxford Muscle Strength Score (Medical Research Council, MRC)
Standard clinical score for evaluation of muscle strength / paresis. Muscle strength is evaluated on a scale between 0/5 (no movement) and 5/5 (full strength) at 8 pre-defined muscles (one proximal and one distal muscle at each extremity).
15 weeks
Vibration Score
Standard clinical score for evaluation of pallesthesia, using a 256 Hz tuning fork. The individual perception threshold for vibration sensations on a scale between 0/8 (no perception) and 8/8 (normal perception) will be determined at 4 predefined spots (processus styloideus radii and malleolus lateralis on each side).
15 weeks
Secondary Outcomes (21)
CIDP Score
1, 7, and 13 weeks
Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score
1, 7, and 13 weeks
Oxford Muscle Strength Score (Medical Research Council, MRC)
16 weeks
Vibration Score
16 weeks
Pain
1, 7, 13, and 15 weeks
- +16 more secondary outcomes
Study Arms (2)
Immunoadsorption
EXPERIMENTAL3 cycles of immunoadsorption in week 1, 7, and 13 after randomization. One cycle consists of 5 sessions on 5 consecutive days with processing of the 2-fold plasma volume on the first day and the 2.5-fold plasma volume on consecutive days, using regenerative adsorbers (Therasorb, Miltenyi Biotec, Bergisch Gladbach)
Immunoglobulins
ACTIVE COMPARATOR5 cycles of intravenous immunoglobulins in week 1, 4, 7, 10, and 13 after randomization. The first cycle consists of 5 intravenous applications of immunoglobulins on 5 consecutive days in a dosage of 0.4 g per kg body weight per day. Subsequent cycles consist of 2 intravenous applications of immunoglobulins on 2 consecutive days in a dosage of 0.5 g per kg body weight per day.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- University of Ulmlead
- Miltenyi Biomedicine GmbHcollaborator
Study Sites (1)
Department of Neurology, University of Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Johannes Dorst, Prof
University of Ulm
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
April 28, 2021
First Posted
May 11, 2021
Study Start
May 1, 2023
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 3 months after publication until 5 years after publication
- Access Criteria
- Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal.
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, and figures), as well as the study protocol will be available. Data will be available beginning 3 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal. Proposals should be directed to johannes.dorst@uni-ulm.de; to gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at https://www.uniklinik-ulm.de/neurologie.html.