| NCT ID | NCT05584631 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | CIDP |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-09-11 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2022-09-11 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Current dosing practices for immunoglobulin G (IgG) may be inadequate in extreme body weight. The current study will evaluate the influence of body composition on intravenous and subcutaneous administration of immunoglobulin G in patients.
Eligibility 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
Contact & Investigator
Luigi Brunetti, PhD
PRINCIPAL INVESTIGATOR
Rutgers, The State University of New Jersey
Frequently Asked Questions
Who can join the NCT05584631 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying CIDP. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05584631 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05584631 currently recruiting?
Yes, NCT05584631 is actively recruiting participants. Contact the research team at brunetti@pharmacy.rutgers.edu for enrollment information.
Where is the NCT05584631 trial being conducted?
This trial is being conducted at New Brunswick, United States.
Who is sponsoring the NCT05584631 clinical trial?
NCT05584631 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Luigi Brunetti, PhD at Rutgers, The State University of New Jersey. The trial plans to enroll 20 participants.