ObesityNCT04818177
Immunoglobulin G Therapy Dose Optimization
An observational study of Obesity and Immune Deficiency, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Immune Deficiency
- What is being tested?
- Institutional standard intravenous immune globulin treatment
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 1 Aug 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients receiving the institutional standard intravenous immune globulin therapy. Differences in IgG concentrations will be analyzed between normal weight subjects (BMI 18.5 - 25 kg/m2) and overweight or obese subjects (BMI > 25 kg/m2).
Who may be able to join
- aged 18 to 75 years
- currently treated with IVIG
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876
About this study
Official title: Optimization of Dosing of Immunoglobulin G in the Obese Population
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.
Read the 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.
- Conditions
- Obesity, Immune Deficiency
- Being tested
- Institutional standard intravenous immune globulin treatment
- Keywords
- Pharmacokinetics, Obesity, Primary immune deficiency, Chronic inflammatory demyelinating polyneuropathy
- Medical subject headings
- Obesity, Immunologic Deficiency Syndromes, Primary Immunodeficiency Diseases, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Institutional standard intravenous immune globulin treatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal Weight | Normal weight is defined as BMI 18.5 - 25 kg/m2. Subjects will receive the institutional standard intravenous immune globulin treatment. Receives: Drug: 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. Receives: Drug: Institutional standard intravenous immune globulin treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum IgG concentrations
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.
Measured: 5 time points (baseline, immediately after dose administration (peak), 2 weeks post dose, just prior to receiving the next scheduled dose (trough))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Apr 2021
- Primary completion1 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Brunetti, Rutgers, The State University of New Jersey
- Investigators
- Luigi Brunetti, Ph D; PharmD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818177
- Sponsor's protocol ID
- Pro20160000739
- Status last verified
- Feb 2026
- First submitted
- 23 Mar 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Dosing of Immunoglobulin G in the Obese Population
- ClinicalTrials.gov ID
- NCT04818177
- Acronym / sponsor ID
- Pro20160000739
- Conditions
- Obesity, Immune Deficiency
- Keywords
- Pharmacokinetics, Obesity, Primary immune deficiency, Chronic inflammatory demyelinating polyneuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Weight | – | Drug: Institutional standard intravenous immune globulin treatmentNormal weight is defined as BMI 18.5 - 25 kg/m2. Subjects will receive the institutional standard intravenous immune globulin treatment. |
| Overweight or Obese | – | Drug: Institutional standard intravenous immune globulin treatmentOverweight or obese is defined as BMI > 25 kg/m2. Subjects will receive the institutional standard intravenous immune globulin treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients receiving the institutional standard intravenous immune globulin therapy. Differences in IgG concentrations will be analyzed between normal weight subjects (BMI 18.5 - 25 kg/m2) and overweight or obese subjects (BMI > 25 kg/m2).
Key inclusion criteria (2 listed)
- aged 18 to 75 years
- currently treated with IVIG
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Institutional standard intravenous immune globulin treatmentNo 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. | Drug | Normal Weight, Overweight or Obese |
Primary outcome
Serum IgG concentrations
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Brunetti, Ph D; PharmD principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Immune Deficiency, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum IgG concentrations (time frame: 5 time points (baseline, immediately after dose administration (peak), 2 weeks post dose, just prior to receiving the next scheduled dose (trough))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.