Actively Recruiting
The Influence of Body Composition on Immunoglobulin Disposition After Intravenous and Subcutaneous Administration
Led by Rutgers, The State University of New Jersey · Updated on 2025-12-11
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how body composition affects the dosing and behavior of immunoglobulin G (IgG) when given intravenously or subcutaneously in adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The study aims to evaluate current dosing practices that may not be adequate for patients with extreme body weights, considering that existing dosing guidelines are mostly based on expert opinions and may not fully account for how adipose tissue influences IgG distribution and metabolism. This research is conducted as a Phase 1 clinical trial sponsored by Rutgers, The State University of New Jersey. Participants will receive either intravenous immune globulin G (IVIG) at their current dose or subcutaneous immune globulin G (SCIG) converted directly from their IVIG dose on a 1-to-1 basis adjusted by body weight. The SCIG dose will be carefully converted to fall within a specific dose range. Both treatments are being studied to compare how IgG behaves in the body depending on administration route and body composition. During the study, participants will have multiple assessments including measurement of IgG serum concentrations at various time points before and after administration, drug half-life evaluation, and monitoring of muscle strength, function, fatigue, and disability. These assessments will happen over approximately four weeks, with blood samples taken before administration, immediately after, and at scheduled days following treatment. The study will also track patient responses and safety throughout the treatment period.
CONDITIONS
Brief Title
IVIG vs SCIG in CIDP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged over 18 years with a current diagnosis of CIDP based on specific diagnostic criteria
- Weekly dose conversion from intravenous to subcutaneous immune globulin G must be within 0.2 to 0.4 mg/kg
You will not qualify if you...
- Patients receiving intravenous immune globulin G for conditions other than CIDP
- Patients with liver enzyme levels more than 3 times the normal limit or reduced kidney function (creatinine clearance less than 50 mL/min)
- Active malignancies
- Diabetes
- Myasthenia gravis
- Immunodeficiency
- Autoimmune disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 4 weeks per treatment period
Participants receive intravenous or subcutaneous immune globulin G based on their current dosing for the treatment of CIDP.
Multiple visits including drug administration and blood sampling on days 0, 2, 4, 7, and 14 depending on treatment
Trial Site Locations
Total: 1 location
1
Rutgers, The State University of New Jersey Clinical Research Center
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
Research Team
L
Luigi Brunetti, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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