Status:

RECRUITING

Immunoglobulin G Therapy Dose Optimization

Lead Sponsor:

Rutgers, The State University of New Jersey

Conditions:

Obesity

Immune Deficiency

Eligibility:

All Genders

18-75 years

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. Ther...

Detailed Description

The estimated prevalence of overweight and obese individuals \>20 years in the US is 154.7 million (nearly double since the early 1960s), and over 1.6 billion people are considered overweight or obese...

Eligibility Criteria

Inclusion

  • aged 18 to 75 years
  • currently treated with IVIG

Exclusion

  • 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

Key Trial Info

Start Date :

April 2 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT04818177

Start Date

April 2 2021

End Date

December 1 2025

Last Update

November 14 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, United States, 08876

Immunoglobulin G Therapy Dose Optimization | DecenTrialz