Immunoglobulin G Therapy Dose Optimization

Description

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.

Conditions

Obesity, Immune Deficiency

Study Overview

Study Details

Study overview

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.

Optimization of Dosing of Immunoglobulin G in the Obese Population

Immunoglobulin G Therapy Dose Optimization

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Somerville

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * aged 18 to 75 years
  • * currently treated with IVIG
  • * 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rutgers, The State University of New Jersey,

Luigi Brunetti, Ph D; PharmD, PRINCIPAL_INVESTIGATOR, Rutgers University

Study Record Dates

2025-12-01