Actively Recruiting
A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Led by Kedrion S.p.A. · Updated on 2026-04-14
161
Participants Needed
2
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 18 years or older
- Written informed consent and permission to access personal health information
- Documented diagnosis of CIDP consistent with 2021 EAN/PNS criteria
- Current or past significant disability with adjusted INCAT disability score between 2 and 9, with a score of 2 only from lower limbs
- Currently dependent on immunoglobulins, corticosteroids, or standard CIDP treatments
- Weakness in at least two limbs
- Clinically stable for 12 weeks before screening without worsening INCAT score, symptom changes, or treatment changes
You will not qualify if you...
- Pure sensory atypical and multivariant CIDP
- Females who are pregnant, breastfeeding, not using contraception, or planning pregnancy during the study
- Previous IGIV dosage over 1.3 g/kg/month or SCIG over 1.6 g/kg/month
- Previous failure to respond to IGIV or SCIG
- Body mass index over 35 kg/m2 or risk of fluid overload from IGIV dose
- CIDP or neuropathy not matching 2021 EAN/PNS criteria
- Immunoglobulin M paraproteinemia or IgM monoclonal gammopathy with high antibodies to myelin-associated glycoprotein
- Central demyelinating disorders or severe muscle disease
- Chronic or debilitating diseases or neurological disorders affecting CIDP assessment
- Severe heart conditions or uncontrolled hypertension
- Recent history of blood clots or thromboembolic events within 12 months
- Conditions affecting protein or IgG metabolism
- Chronic kidney disease with low filtration rate
- Active cancer requiring treatment or recent cancer remission under 2 years
- Allergic reactions to human blood products
- Known immunoglobulin A deficiency
- Autoimmune nodo-paranodopathies resistant to immunoglobulin treatment
- Abnormal liver enzymes, low platelets, low neutrophils, or significant anemia at screening
- Active hepatitis B, C, or HIV infections except treated chronic hepatitis with undetectable viral load
- Recent treatments including plasma exchange, certain immunosuppressive drugs, or stem cell transplant within specified timeframes
- Use of corticosteroids for CIDP after washout, except low-dose for unrelated conditions
- Any condition or factor that impairs study participation or safety
- Participation in another clinical study with investigational products within 30 days
- History of thrombophilic disorders
- Previous participation in this clinical study
- Other factors preventing compliance with the study protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
USF Health - Morsani Center for Advanced Healthcare
Tampa, Florida, United States, 33613
Actively Recruiting
2
Advanced Neurology Epilepsy and Sleep Center/ANESC Research
El Paso, Texas, United States, 79912
Actively Recruiting
Research Team
A
Anna Lotti Suffredini
CONTACT
E
Esra Cinar-Jones
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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