Comparing IVIG and SCIG dosing for CIDP
Official title: The Influence of Body Composition on Immunoglobulin Disposition After Intravenous and Subcutaneous Administration
Run by Rutgers, The State University of New Jersey · NCT05584631 · Data updated 2026-11-12
This trial will test whether body composition changes how IVIG and SCIG deliver protective antibodies in adults with CIDP.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 1 site (New Brunswick, New Jersey) |
| Status | Recruiting |
| Started | September 11, 2022 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | December 11, 2025 |
| Trial ID | NCT05584631 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with a current CIDP diagnosis by EFNS/PNS criteria who can be converted from IVIG to weekly SCIG within the specified 1:1 conversion and dosing range are ideal candidates.
✕Probably not a fit
Patients with excluded comorbidities such as diabetes, active malignancy, immunodeficiency, myasthenia gravis, or significant liver or renal impairment are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1 interventional pharmacokinetic study comparing intravenous (IVIG) and subcutaneous (SCIG) immunoglobulin G administration in adults with CIDP, with attention to total, ideal, and adjusted body weight-based dosing strategies. Participants who meet EFNS/PNS diagnostic criteria for CIDP will convert from IVIG to weekly SCIG within a specified 1:1 conversion and undergo serial serum sampling to map IgG pharmacokinetics across different body compositions. Patients with significant liver or renal impairment, diabetes, active malignancy, myasthenia gravis, immunodeficiency, or other autoimmune diseases are excluded. The study is conducted at the Rutgers Clinical Research Center in New Brunswick, New Jersey.
Why it matters
Potential benefit: If successful, the study could clarify dosing by body composition, leading to more accurate IgG dosing, better symptom control, and fewer wasted or capped doses.
How similar studies have gone: Prior observational studies and the PATH trial provided mixed or incomplete evidence linking serum IgG levels to clinical outcomes, and PK-focused interventional work like this remains relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged \>18 years with a current diagnosis of CIDP (based on European Federation of Neurological sciences / Peripheral Nerve Society CIDP diagnostic criteria). * 1:1 conversion of IVIG to SCIG (weekly dose conversion) must fall within 0.2-to-0.4 mg/kg dose for SCIG. Exclusion Criteria: * Patients receiving IVIG for indications other than CIDP will be excluded. * Patients with liver impairment (elevations in liver enzymes of greater than 3 times the upper limit of normal) or reduced renal function (CrCl \< 50 mL/min) will be excluded * Active malignancies * Diabetes * Myasthenia gravis * Immunodeficiency * Autoimmune disease
Where it's running
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Rutgers, The State University of New Jersey Clinical Research Center
New Brunswick, New Jersey, United States Recruiting
Study contacts
- Principal investigator: Luigi Brunetti, PhD — Rutgers, The State University of New Jersey
- Study coordinator: Luigi Brunetti, PhD
- Email: brunetti@pharmacy.rutgers.edu
- Phone: 2016385868
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.