Clinical trial NCT05584631: IVIG Vs SCIG in CIDP
Official title: The Influence of Body Composition on Immunoglobulin Disposition After Intravenous and Subcutaneous Administration
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: CIDP
Immunoglobulin Deficiency
Chronic Inflammatory Demyelinating Polyneuropathy
Keywords: immunoglobulin
pharmacokinetics
obesity
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Detailed 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. While this assertion is logical, it does not account for changes adipose tissue may confer on target sites, nor does it account for the potential for adipose tissue to function serve as a metabolic sink or a source of inflammatory mediators. The later would be especially important in patients receiving SCIG. Several observational studies have evaluated IgG dosing in obese patients and have been the source of support for dosing strategies. Many of these studies were not representative of specific populations, contained a wide variety of patients with different IgG indications, and had inadequate serum sampling. More recently, the phase III randomized controlled PATH trial did not find a correlation with serum IgG concentrations and clinical endpoints. However, it is important to note that the study was not designed to evaluate pharmacokinetic and pharmacodynamic endpoints. There is also considerable interpatient variation in response; therefore, identification of patient characteristics that predict response or IgG change from baseline will be a useful tool to improve patient responses. Our study will evaluate the influence of body composition and other patient characteristics may have on IgG exposure when given intravenously or subcutaneously.

Eligibility criteria: 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
* Diabetes
* Myasthenia gravis
* Immunodeficiency
* Autoimmune disease

Primary outcomes:
measure: Assessment of drug half-life
timeFrame: Through study completion, an average of 4 weeks
measure: Assessment of immune globulin G serum concentration after intravenous immune globulin G administration
timeFrame: Just before drug administration, immediately after drug administration, approximately days 7 and 14 post drug administration
measure: Assessment of immune globulin G serum concentration after subcutaneous immune globulin G administration
timeFrame: Just before drug administration, immediately after drug administration, approximately days 2, 4 and 7 post drug administration
Secondary outcomes:
measure: Assessment of grip strength
timeFrame: Baseline and just before administration of next immune globulin dose.
measure: Assessment of muscle function
timeFrame: Baseline and just before administration of next immune globulin dose.
measure: Assessment of patient disability
timeFrame: Baseline and just before administration of next immune globulin dose.
measure: Assessment of fatigue
timeFrame: Baseline and just before administration of next immune globulin dose.
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers, The State University of New Jersey Clinical Research Center
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Luigi Brunetti, PhD
role: PRINCIPAL_INVESTIGATOR
References: