Optimizing immunoglobulin G dosing for obese patients
Optimization of Dosing of Immunoglobulin G in the Obese Population
This study is trying to find the best way to dose immunoglobulin G for obese patients to make sure they get the right amount for effective treatment and fewer side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 1 site (Somerville, New Jersey) |
| Trial ID | NCT04818177 on ClinicalTrials.gov |
What this trial studies
This study investigates how obesity affects the pharmacokinetics of immunoglobulin G (IgG) and aims to develop optimal dosing strategies for IgG in obese patients. It addresses the lack of consensus on dosing methods, such as total body weight versus ideal or adjusted body weight, which may impact treatment efficacy and safety. The study will analyze the clinical implications of different dosing strategies to minimize adverse reactions and improve outcomes for patients receiving intravenous immune globulin treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 who are currently receiving intravenous immunoglobulin therapy.
Not a fit: Patients with liver impairment, reduced renal function, or those with a pacemaker or automatic implantable cardioverter-defibrillator may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective dosing strategies for immunoglobulin G in obese patients, improving their treatment outcomes.
How similar studies have performed: While there is ongoing debate regarding IgG dosing in obese patients, this study addresses a gap in the literature and may provide novel insights into this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Somerville, New Jersey
- Robert Wood Johnson University Hospital Somerset — Somerville, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Luigi Brunetti, Ph D; PharmD — Rutgers University
- Study coordinator: Luigi Brunetti, Ph D; PharmD
- Email: luigi.brunetti@rutgers.edu
- Phone: 7324455215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.