IVIG vs SCIG in CIDP
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravenous immune globulin G, Subcutaneous immune globulin G.
- Who it may be relevant to
- Registry conditions: CIDP, Immunoglobulin Deficiency, Chronic Inflammatory Demyelinating Polyneuropathy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Influence of Body Composition on Immunoglobulin Disposition After Intravenous and Subcutaneous Administration
Overview
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.
Interventions
- Drug Intravenous immune globulin G
Intravenous immune globulin G dosed based on the subjects's current dose received for the treatment of CIDP. - Drug Subcutaneous immune globulin G
Subcutaneous immune globulin G converted from the subject's current IVIG dose 1:1.
Primary outcome measures
- Assessment of drug half-life [Time frame: Through study completion, an average of 4 weeks]
- Assessment of immune globulin G serum concentration after intravenous immune globulin G administration [Time frame: Just before drug administration, immediately after drug administration, approximately days 7 and 14 post drug administration]
- Assessment of immune globulin G serum concentration after subcutaneous immune globulin G administration [Time frame: Just before drug administration, immediately after drug administration, approximately days 2, 4 and 7 post drug administration]
Secondary outcome measures (4)
- Assessment of grip strength [Time frame: Baseline and just before administration of next immune globulin dose.]
- Assessment of muscle function [Time frame: Baseline and just before administration of next immune globulin dose.]
- Assessment of patient disability [Time frame: Baseline and just before administration of next immune globulin dose.]
- Assessment of fatigue [Time frame: Baseline and just before administration of next immune globulin dose.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Rutgers, The State University of New Jersey Clinical Research Center — New Brunswick
Identifiers
NCT: NCT05584631 · Pro2019001038