A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Part of paid clinical trials in Tampa, Florida.

Sponsor
Kedrion S.p.A.
Study ID
NCT06752356
Phase
PHASE3
Status
Recruiting
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Conditions

  • Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Immune globulin (human) 10% solution for intravenous administration — BIOLOGICAL
    Kedrion intravenous immunoglobulin (IVIg) 10%

Study Details

The current study is being conducted to assess the efficacy and safety of KIg10 (Intravenous Human Immune globulin 10%) at two different dosages as maintenance therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) following 21 weeks of treatment.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Dec 20, 2027
Completion
Dec 27, 2027

Study Design

Enrollment
161 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1.0 g/kg dose group for 24 weeks
    This group will receive, initial loading dose of 2.0 g/kg of Intravenous (IV) KIg10 (Immunoglobulin) infusion followed by 1.0 g/kg of IV KIg10 every 3 weeks.
  • Experimental: 0.5 g/kg dose group for 24 weeks
    This group will receive, Initial loading dose of 2.0 g/kg of Intravenous (IV) KIg10 (Immunoglobulin) infusion will be given followed by 0.5 g/kg of IV KIg10 every 3 weeks.

Primary Outcome Measure

Efficacy of 1.0 g/kg KIg10 in the treatment of adult subjects with active CIDP [ Time Frame: From Baseline upto 24 weeks of treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
USF Health - Morsani Center for Advanced HealthcareTampaFlorida33613
Kathleen Murray (PRINCIPAL_INVESTIGATOR)
Advanced Neurology Epilepsy and Sleep Center/ANESC ResearchEl PasoTexas79912
Aamr Herekar (PRINCIPAL_INVESTIGATOR)

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By research site
USF Health - Morsani Center for Advanced Healthcare· Tampa, FLAdvanced Neurology Epilepsy and Sleep Center/ANESC Research· El Paso, TX

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