The Influence of Body Composition on Immunoglobulin Disposition After Intravenous and Subcutaneous Administration

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.

IVIG vs SCIG in CIDP