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Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

NCT ID: NCT04881682

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2026-03-01

Brief Summary

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This is a randomized controlled study evaluating safety and efficacy of repeated immunoadsorption versus immunoglobulins in steroid-refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

Detailed Description

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Conditions

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CIDP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Immunoadsorption

3 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)

Group Type EXPERIMENTAL

Immunoadsorption

Intervention Type DEVICE

see arm/group description

Immunoglobulins

5 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.

Group Type ACTIVE_COMPARATOR

Immunoglobulins

Intervention Type BIOLOGICAL

see arm/group description

Interventions

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Immunoadsorption

see arm/group description

Intervention Type DEVICE

Immunoglobulins

see arm/group description

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Miltenyi Biomedicine GmbH

INDUSTRY

Sponsor Role collaborator

University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Albert Christian Ludolph, Prof.

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johannes Dorst, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Ulm

Locations

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Department of Neurology, University of Ulm

Ulm, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Johannes Dorst, Prof

Role: CONTACT

Phone: +49 731 177 5285

Email: [email protected]

Facility Contacts

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Albert C Ludolph, MD, Prof.

Role: primary

Other Identifiers

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IVITOC 1.1

Identifier Type: -

Identifier Source: org_study_id