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Obesity may affect immune drug dosing – study seeks answers

NCT ID NCT04818177

Knowledge-focused Sponsor: Rutgers, The State University of New Jersey Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study investigates how obesity affects the way the body processes intravenous immune globulin (IVIG), a treatment for immune deficiencies. Researchers measured body composition and blood levels of IVIG in 40 obese and normal-weight patients to find the best dosing strategy. The goal is to reduce side effects from overdosing and ensure effective treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
intravenous immune globulin (IVIG)
What this could lead to
If successful, this study could lead to better dosing guidelines for IVIG in obese patients, reducing side effects and improving treatment outcomes.
What could go wrong
This is a small, observational study with only 40 participants, so results may not apply to all patients. It does not test a new treatment, only refines existing dosing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

40 people

The number who actually took part.

Started

Apr 2021

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic inflammatory demyelinating polyradiculoneuropathy immunodeficiency disease inborn error of immunity Obesity obesity disorder Primary Immunodeficiency Diseases

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immune deficiency Obesity

Contacts and locations

Locations

  • Robert Wood Johnson University Hospital Somerset

    Somerville, New Jersey, 08876, United States

More trials for these conditions

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