The Influence of Body Composition on Immunoglobulin Disposition After Intravenous and Subcutaneous Administration
Rutgers, The State University of New Jersey
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.
Description
Current dosing practices for immunoglobulin G (IgG) may be inadequate in extreme body weight. Total (TBW), ideal (IBW), and adjusted (AdjBW) body weight-based dosing strategies are suggested, but these recommendations are based on expert opinion rather than high quality evidence. The adoption of a specific strategy is highly variable depending on the clinician and/or institutional setting. Recently, payors have also adopted strategies to reduce IgG therapy costs of by capping doses. These recommendations are often based on the presumption that IgG distribution is limited to the vascular space.…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients aged \>18 years with a current diagnosis of CIDP (based on European Federation of Neurological sciences / Peripheral Nerve Society CIDP diagnostic criteria). * 1:1 conversion of IVIG to SCIG (weekly dose conversion) must fall within 0.2-to-0.4 mg/kg dose for SCIG. Exclusion Criteria: * 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 * Diabe…
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.
Location
- Rutgers, The State University of New Jersey Clinical Research CenterNew Brunswick, New Jersey