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COMPLETED

Immunoglobulin G Therapy Dose Optimization

NCT04818177 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Institutional standard intravenous immune globulin treatment

Study Locations (1)

New Jersey

  • Robert Wood Johnson University Hospital Somerset — Somerville

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2021-04-01
Est. Completion 2025-08-01

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04818177

The ClinicalTrials.gov registry entry for NCT04818177 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rutgers, The State University of New Jersey, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention — of which Institutional standard intravenous immune globulin treatment is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04818177 reports 1 study location spanning 1 distinct geographic area — top geographies include New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04818177 about?

NCT04818177 is a clinical study titled "Immunoglobulin G Therapy Dose Optimization". 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. ...

What is the current status of trial NCT04818177?

This trial is currently completed. The enrollment target is 40 participants. The study started on 2021-04-01. Estimated completion is 2025-08-01.

What conditions does trial NCT04818177 study?

This clinical trial studies the following conditions: Obesity, Immune Deficiency. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04818177?

The interventions under investigation include: Institutional standard intravenous immune globulin treatment (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04818177?

This trial is sponsored by Rutgers, The State University of New Jersey, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04818177 being conducted?

This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial