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Immunoadsorption for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Study acronym: IFTOC
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary endpoint revised
    • Secondary endpoints: details revised at 5 of 11 entries
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT07154524
Lead Sponsor University of Ulm
Collaborators: Fresenius Medical Care Deutschland GmbH
Conditions
(from sponsor)		 Chronic Inflammatory Demyelinating Polyneuropathy
Related terms Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov