A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT06752356 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 161
Last updated 2026-04-14
Summary
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.
Conditions
Interventions
- BIOLOGICAL
-
Immune globulin (human) 10% solution for intravenous administration
Kedrion intravenous immunoglobulin (IVIg) 10%
Sponsors & Collaborators
-
Kedrion S.p.A.
lead INDUSTRY
Principal Investigators
-
Lakshmi Deshpande · Kedrion S.p.A.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2027-12-20
- Completion
- 2027-12-27
- FDA Drug
- Yes
Countries
- United States
Study Locations
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