Immunoglobulin G Therapy Dose Optimization

Recruiting

• Conditions: Obesity; Immune Deficiency
• Interventions: Drug: Institutional standard intravenous immune globulin treatment

• Registration Number: NCT04818177
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-26
• Study Start: 2021-04-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Serum IgG concentrations	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.

Trial Locations

Locations (1)

Robert Wood Johnson University Hospital Somerset; 🇺🇸 Somerville, New Jersey, United States