RecruitingPhase 2NCT04881682

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


Sponsor

University of Ulm

Enrollment

20 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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

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Interventions

DEVICEImmunoadsorption

see arm/group description

BIOLOGICALImmunoglobulins

see arm/group description


Locations(1)

Department of Neurology, University of Ulm

Ulm, Baden-Wurttemberg, Germany

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NCT04881682


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