Immunoglobulin G Therapy Dose Optimization

NCT04818177 | Completed FDA Drug

• 1 other identifier: Pro20160000739
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Immune Deficiency

Keywords

Pharmacokinetics; Obesity; Primary immune deficiency; Chronic inflammatory demyelinating polyneuropathy

Outcome Measures

Primary Outcomes (1)

• 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.

  5 time points (baseline, immediately after dose administration (peak), 2 weeks post dose, just prior to receiving the next scheduled dose (trough))

Study Arms (2)

Normal Weight

Normal weight is defined as BMI 18.5 - 25 kg/m2. Subjects will receive the institutional standard intravenous immune globulin treatment.

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.

Drug: Institutional standard intravenous immune globulin treatment

Interventions

Institutional standard intravenous immune globulin treatment DRUG

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.

Normal Weight; Overweight or Obese

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• aged 18 to 75 years
• currently treated with IVIG

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, 08876, United States

Location

MeSH Terms

Conditions

Obesity; Immunologic Deficiency Syndromes; Primary Immunodeficiency Diseases; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Immune System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Luigi Brunetti, Ph D; PharmD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: April 1, 2021
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)