NCT07154524

Brief Summary

This study is designed as an explorative study aiming at exploring safety and efficacy of immunoadsorption (IA) in patients with Chronic Inflammatory Demyelinating Poly-neuropathy (CIDP) compared to intravenous immunoglobulins (IVIg) and methyl-prednisolone (MP). For this purpose, approximately 140 patients with CIDP will be included within the framework of the German multicenter network "Kompetenznetz Peripherer Nerv" (KKPNS). The study will be purely observational. IA will be performed as an escalation therapy, i.e., in patients who did not respond to IVIg and/or MP treatment. Patients will be included in the study during ongoing IVIg or MP treatment and switched to IA during the 18-month observation period in case of an insufficient response. IA will be performed according to the therapeutic scheme of each participating center. A non-mandatory recommendation for number of sessions, treatment volumes, and frequency will be given (see below). Six-month follow-up visits including collection of standardized clini-cal data will be performed.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
41mo left

Started Aug 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress17%
Aug 2025Aug 2029

First Submitted

Initial submission to the registry

August 27, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

August 27, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2029

Last Updated

September 11, 2025

Status Verified

August 1, 2025

Enrollment Period

3.5 years

First QC Date

August 27, 2025

Last Update Submit

September 4, 2025

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

Chronic Inflammatory Demyelinating PolyneuropathyImmunoadsorptionLong-term effectstherapy-refractory

Outcome Measures

Primary Outcomes (1)

  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score

    The CIDP score is a combined clinical score comprising the Inflammatory Neuropathy Cause and Treatment Score (INCAT), the Medical Research Council (MRC) and Vibrations Sensitivity Testing with a 256 Hz Ryder-Seiffel tuning fork. Range 0-480, higher values signify better outcome.

    18 months

Secondary Outcomes (11)

  • Inflammatory Neuropathy Cause and Treatment Score (INCAT)

    18 months

  • Medical Research Council (MRC)

    18 months

  • Vibration Sensitivity

    18 months

  • Inflammatory Rasch-built Overall Disability Scale (I-RODS)

    18 months

  • Overall Neuropathy Limitations Scale (ONLS)

    18 months

  • +6 more secondary outcomes

Study Arms (1)

Immunoadsorption

Patients receiving Immunoadsorption as an escalation therapy after unsuccessful treatment with immunoglobulins or steroids

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CIDP patients currently under treatment with immunoglobulins or steroids will be included in the study.

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

PolyradiculoneuropathyAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Johannes Dorst

    University of Ulm

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Dorst, Prof. Dr.

CONTACT

+497311775285johannes.dorst@uni-ulm.de

Zeynep Elmas

CONTACT

+497311775282zeynep.elmas@uni-ulm.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 4, 2025

Study Start

August 27, 2025

Primary Completion (Estimated)

February 27, 2029

Study Completion (Estimated)

August 27, 2029

Last Updated

September 11, 2025

Record last verified: 2025-08

Locations

DE(1)