Optimization of Dosing of Immunoglobulin G in the Obese Population
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• aged 18 to 75 years
• currently treated with IVIG
Locations
United States
New Jersey
Robert Wood Johnson University Hospital Somerset
RECRUITING
Somerville
Contact Information
Primary
Luigi Brunetti, Ph D; PharmD
luigi.brunetti@rutgers.edu
7324455215
Backup
Christine N Yohn, Ph D
cy253@pharmacy.rutgers.edu
9083284210
Time Frame
Start Date: 2021-04-02
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 40
Treatments
Normal Weight
Normal weight is defined as BMI 18.5 - 25 kg/m2. Subjects will receive the institutional standard intravenous immune globulin treatment.
Overweight or Obese
Overweight or obese is defined as BMI \> 25 kg/m2. Subjects will receive the institutional standard intravenous immune globulin treatment.
Authors
Luigi Brunetti
Related Therapeutic Areas
Sponsors
Leads: Rutgers, The State University of New Jersey