Immunoglobulin G Therapy Dose Optimization

February 12, 2026 updated by: Luigi Brunetti, Rutgers, The State University of New Jersey

Optimization of Dosing of Immunoglobulin G in the Obese Population

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Somerville, New Jersey, United States, 08876
        • Robert Wood Johnson University Hospital Somerset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male and female patients receiving the institutional standard intravenous immune globulin therapy. Differences in IgG concentrations will be analyzed between normal weight subjects (BMI 18.5 - 25 kg/m2) and overweight or obese subjects (BMI > 25 kg/m2).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal Weight
Normal weight is defined as BMI 18.5 - 25 kg/m2. Subjects will receive the institutional standard intravenous immune globulin treatment.
Drug: Institutional standard intravenous immune globulin treatment
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.
Overweight or Obese
Overweight or obese is defined as BMI > 25 kg/m2. Subjects will receive the institutional standard intravenous immune globulin treatment.
Drug: Institutional standard intravenous immune globulin treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 time points (baseline, immediately after dose administration (peak), 2 weeks post dose, just prior to receiving the next scheduled dose (trough))

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Investigators

  • Principal Investigator: Luigi Brunetti, Ph D; PharmD, Rutgers University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

August 1, 2025

Study Registration Dates

First Submitted

March 23, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (Actual)

March 26, 2021

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro20160000739

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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