RECRUITING

Immunoglobulin G Therapy Dose Optimization

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Optimization of Dosing of Immunoglobulin G in the Obese Population

Quick Facts

Study Start:2021-04-02
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04818177

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * aged 18 to 75 years
  2. * currently treated with IVIG
  1. * liver impairment (elevations in liver enzymes of greater than 3 times the upper limit of normal)
  2. * reduced renal function (CrCl \< 50 mL/min)
  3. * Patients with a pacemaker or an automatic implantable cardioverter-defibrillator

Contacts and Locations

Study Contact

Luigi Brunetti, Ph D; PharmD
CONTACT
7324455215
luigi.brunetti@rutgers.edu
Christine N Yohn, Ph D
CONTACT
9083284210
cy253@pharmacy.rutgers.edu

Principal Investigator

Luigi Brunetti, Ph D; PharmD
PRINCIPAL_INVESTIGATOR
Rutgers University

Study Locations (Sites)

Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

  • Luigi Brunetti, Ph D; PharmD, PRINCIPAL_INVESTIGATOR, Rutgers University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-02
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2021-04-02
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Obesity
  • Immune Deficiency