The Influence of Body Composition on Immunoglobulin G Disposition After Intravenous and Subcutaneous Administration in Chronic Inflammatory Demyelinating Polyneuropathy

What this Trial Is About

Researchers are investigating how body composition affects the way immunoglobulin G (IgG) is processed when given intravenously or subcutaneously in patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The study focuses on whether current IgG dosing methods, especially in people with extreme body weights, are adequate, as existing guidelines vary widely and are based mostly on expert opinion rather than solid evidence. This trial aims to better understand the relationship between body weight, tissue types, and IgG exposure to improve treatment strategies. The study compares two methods of IgG administration: intravenous immune globulin G (IVIG), dosed based on each patient’s current treatment, and subcutaneous immune globulin G (SCIG), where the dose is converted from the patient’s IVIG dose on a 1-to-1 basis. The SCIG dose is adjusted to fall within a specific range relative to body weight. This trial is a Phase 1 study designed to assess how body composition influences IgG distribution and metabolism for these two delivery methods. Participants will be monitored for drug half-life and IgG serum concentrations at various time points before and after treatment. For IVIG, blood samples will be taken just before, immediately after, and around days 7 and 14 post-administration. For SCIG, samples are collected just before, immediately after, and on days 2, 4, and 7 after administration. The study will track the patients’ responses and drug levels to better understand how IgG behaves in the body and to identify patient characteristics that affect treatment outcomes.

IVIG vs SCIG in CIDP