NCT05584631

IVIG vs SCIG in CIDP

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Current dosing practices for immunoglobulin G (IgG) may be inadequate in extreme body weight. Total (TBW), ideal (IBW), and adjusted (AdjBW) body weight-based dosing strategies are suggested, but these recommendations are based on expert opinion rather than high quality evidence. The adoption of a specific strategy is highly variable depending on the clinician and/or institutional setting. Recently, payors have also adopted strategies to reduce IgG therapy costs of by capping doses. These recommendations are often based on the presumption that IgG distribution is limited to the vascular space. While this assertion is logical, it does not account for changes adipose tissue may confer on target sites, nor does it account for the potential for adipose tissue to function serve as a metabolic sink or a source of inflammatory mediators. The later would be especially important in patients receiving SCIG. Several observational studies have evaluated IgG dosing in obese patients and have been the source of support for dosing strategies. Many of these studies were not representative of specific populations, contained a wide variety of patients with different IgG indications, and had inadequate serum sampling. More recently, the phase III randomized controlled PATH trial did not find a correlation with serum IgG concentrations and clinical endpoints. However, it is important to note that the study was not designed to evaluate pharmacokinetic and pharmacodynamic endpoints. There is also considerable interpatient variation in response; therefore, identification of patient characteristics that predict response or IgG change from baseline will be a useful tool to improve patient responses. Our study will evaluate the influence of body composition and other patient characteristics may have on IgG exposure when given intravenously or subcutaneously.

Conditions

• CIDP
• Immunoglobulin Deficiency
• Chronic Inflammatory Demyelinating Polyneuropathy

Interventions

Type	Name	Description
DRUG	Intravenous immune globulin G	Intravenous immune globulin G dosed based on the subjects's current dose received for the treatment of CIDP.
DRUG	Subcutaneous immune globulin G	Subcutaneous immune globulin G converted from the subject's current IVIG dose 1:1.

Timeline

• Start date: 2022-09-11
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-10-18
• Last updated: 2025-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study