Body fat may change how well immune therapy works
NCT ID NCT05584631
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at how a person's body composition (fat and muscle) affects the way immunoglobulin G (IgG) moves through the body after being given through a vein or under the skin. Researchers will enroll 20 adults with a nerve condition called CIDP who already receive IgG therapy. The goal is to see if current dosing is adequate for people with very high or low body weight.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Immune globulin G (IVIG and SCIG)
- What this could lead to
- If successful, this could lead to more personalized dosing of immunoglobulin therapy for people with CIDP, especially those with extreme body weights.
- What could go wrong
- This is a very small, early-phase study (20 people) focused on drug levels, not on treatment outcomes. Results may not change current practice or apply to all patients.
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.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients aged \>18 years with a current diagnosis of CIDP (based on European Federation of Neurological sciences / Peripheral Nerve Society CIDP diagnostic criteria). * 1:1 conversion of IVIG to SCIG (weekly dose conversion) must fall within 0.2-to-0.4 mg/kg dose for SCIG. Exclusion Criteria: * Patients receiving IVIG for indications other than CIDP will be excluded. * Patients with liver impairment (elevations in liver enzymes of greater than 3 times the upper limit of normal) or reduced renal function (CrCl \< 50 mL/min) will be excluded * Active malignancies * Diabetes * Myasthenia gravis * Immunodeficiency * Autoimmune disease
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Rutgers, The State University of New Jersey Clinical Research Center
RECRUITINGNew Brunswick, New Jersey, 08901, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Ultrasound probes nerve stiffness in rare nerve diseases
- Can a new antibody calm the immune attack in CIDP?
- Could a simple blood test track nerve damage? a study investigates NT-3 levels in neuropathy.
- Ultrasound and blood markers may unlock personalized treatment for rare nerve disease
- New hope for teens with rare nerve disease: drug trial launches
- Blood filtering vs. antibody therapy: new hope for nerve disorder patients