Immunoglobulin G Therapy Dose Optimization

The overall goal of this proposal is to investigate effects of obesity on pharmacokinetics of immunoglobulin G (IgG) and to develop strategies for optimization of dosing of IgG in obese patients. There is an ongoing debate regarding the most appropriate dosing of IgG formulations in obese patients. Obesity poses significant health risks; and evidence supporting dosing strategies of IgG in obese patients is inadequate. Some of the adverse reactions have been attributed to a relative overdosing in these patients, due to a limited distribution of IgG into fat tissue.

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Key information

Conditions

Obesity Autoimmune Diseases Autoimmune Diseases of the Nervous System Body Weight Chronic Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Demyelinating Diseases Disease Attributes Genetic Diseases, Inborn Immune Deficiency Immune System Diseases Immunologic Deficiency Syndromes Nervous System Diseases Neuromuscular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Primary Immunodeficiency Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, 08876, United States

About this study

The estimated prevalence of overweight and obese individuals >20 years in the US is 154.7 million (nearly double since the early 1960s), and over 1.6 billion people are considered overweight or obese worldwide. Compounding the health risks associated with obesity is the insufficient data supporting dosing strategies for a variety of medication used to treat conditions encountered in obese patients. No consensus on the best dosing strategy for IgG in obese patients has been established. Total (TBW), ideal (IBW), and adjusted (AdjBW) body weight-based dosing are being utilized by different institutions. Thus, there is an urgent need to identify evidence supporting optimal dosing strategies for IgG.

It has been proposed that using TBW to dose IgG in obese patients may increase the risk of thrombosis owing to increased blood viscosity, activation of platelets, or vasospasm; and the increase in blood viscosity has been reported as IgG dose dependent. The use of using IBW or AdjBW has been advocated to reduce the side effect and drug expenditures. It is currently unknown what the clinical impact is of using measures of body weight other than TBW to calculate IgG doses, and the effect of obesity on IgG pharmacokinetics has not been experimentally evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

aged 18 to 75 years
currently treated with IVIG

Exclusion criteria

liver impairment (elevations in liver enzymes of greater than 3 times the upper limit of normal)
reduced renal function (CrCl < 50 mL/min)
Patients with a pacemaker or an automatic implantable cardioverter-defibrillator

Treatment and study plan

Institutional standard intravenous immune globulin treatment

Drug

No treatments will be prospectively assigned. Subjects will receive their standard intravenous immune globulin doses. We will measure body composition and identify the relationship between body composition and intravenous immune globulin disposition.

Primary outcomes

Serum IgG concentrations

Time frame: 5 time points (baseline, immediately after dose administration (peak), 2 weeks post dose, just prior to receiving the next scheduled dose (trough))

A linear mixed effects model to analyze serum IgG concentrations, with normal/obese as the primary predictor but with clinical and demographic variables as covariates.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

Optimization of Dosing of Immunoglobulin G in the Obese Population

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Mar 26, 2021
Registry last updated: Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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