RecruitingPhase 1NCT05584631

IVIG vs SCIG in CIDP

The Influence of Body Composition on Immunoglobulin Disposition After Intravenous and Subcutaneous Administration


Sponsor

Rutgers, The State University of New Jersey

Enrollment

20 participants

Start Date

Sep 11, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Current dosing practices for immunoglobulin G (IgG) may be inadequate in extreme body weight. The current study will evaluate the influence of body composition on intravenous and subcutaneous administration of immunoglobulin G in patients.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

  • Patients aged \>18 years with a current diagnosis of CIDP (based on European Federation of Neurological sciences / Peripheral Nerve Society CIDP diagnostic criteria).
  • :1 conversion of IVIG to SCIG (weekly dose conversion) must fall within 0.2-to-0.4 mg/kg dose for SCIG.

Exclusion Criteria7

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIntravenous immune globulin G

Intravenous immune globulin G dosed based on the subjects's current dose received for the treatment of CIDP.

DRUGSubcutaneous immune globulin G

Subcutaneous immune globulin G converted from the subject's current IVIG dose 1:1.


Locations(1)

Rutgers, The State University of New Jersey Clinical Research Center

New Brunswick, New Jersey, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05584631


Related Trials