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

Related Clinical Trial
CIDP07 Rozanolixizumab Post Trial Access Program (the PTA) Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Hizentra® in Inflammatory Neuropathies – pHeNIx Study Proof-of-concept Study for BIVV020 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC) InertiaLocoGraphy as a Biomarker of Immunoglobulin Therapy Efficacy in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Rituximab in Chronic Inflammatory Demyelinating Polyneuropathy: A Phase II Study Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy A Registered Cohort Study of Immune-Mediated Neuropathies Interest of Mycophenolate for CIDP Weaning Efficacy and Safety Study of I10E in Treatment of Patients With CIDP Transcriptome Analysis of the Peripheral Blood in CIDP Phase III Efficacy, Safety, and Tolerability Study of HYQVIA/HyQvia and GAMMAGARD LIQUID/KIOVIG in CIDP Safety and Efficacy Study of Three Different Dosages of NewGam in Patients With CIDP Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302 Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP Subcutaneous Immunoglobulin for CIDP Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP The Evaluation of Efficacy and Safety of Rituximab in Refractory CIDP Patients With IgG4 Autoantibodies Single vs. Multiple Privigen Dose Regimens in Pediatric CIDP Hematopoietic Stem Cell Transplantation in Chronic Inflammatory Demyelinating Polyneuropathy Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy MRI in Diagnosing and Monitoring CIDP High-dose Cyclophosphamide for Moderate to Severe Refractory Chronic Inflammatory Demyelinating Polyneuropathy Biomark Study: Predict Intravenous Immunoglobulin Responders in Chronic Inflammatory Demyelinating Polyradiculoneuropathy A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves) Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy. IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength Measurements A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves) Safety and Efficacy of Avonex in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients. Prevalence of Decreased Corneal Sensation in Patients With Chronic Inflammatory Demyelinating Polyneuropathy Panzyga in CIDP Administered at Different Infusion Rates Study of Efficacy and Safety of Privigen in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20) A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Brief Title

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

Official Title

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

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).
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

CIDP Score

Secondary Outcome

 CIDP Score

Condition

CIDP

Intervention

Immunoadsorption

Study Arms / Comparison Groups

 Immunoadsorption
Description:  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)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

20

Start Date

June 1, 2021

Completion Date

October 1, 2023

Primary Completion Date

October 1, 2023

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Johannes Dorst, Prof, +49 731 177 5285, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT04881682

Organization ID

IVITOC 1.1


Responsible Party

Principal Investigator

Study Sponsor

University of Ulm

Collaborators

 Miltenyi Biomedicine GmbH

Study Sponsor

Johannes Dorst, Prof, Principal Investigator, University of Ulm


Verification Date

May 2021