Immunoglobulin G Therapy Dose Optimization

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Recruiting
CT.gov ID
NCT04818177
Collaborator
(none)
40
1
22.9
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Institutional standard intravenous immune globulin 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
40 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Optimization of Dosing of Immunoglobulin G in the Obese Population
Actual Study Start Date :
Apr 2, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Robert Wood Johnson University Hospital Somerset Somerville New Jersey United States 08876

Sponsors and Collaborators

  • Rutgers, The State University of New Jersey

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Luigi Brunetti, PharmD, PhD, Associate Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT04818177
Other Study ID Numbers:
  • Pro2019001038
First Posted:
Mar 26, 2021
Last Update Posted:
Feb 28, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Keywords provided by Luigi Brunetti, PharmD, PhD, Associate Professor, Rutgers, The State University of New Jersey
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 28, 2022