CIDPPhase 1NCT05584631
IVIG vs SCIG in CIDP
A Phase 1 study testing Intravenous immune globulin G and Subcutaneous immune globulin G in people with CIDP and Immunoglobulin Deficiency, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- CIDP, Immunoglobulin Deficiency, Chronic Inflammatory Demyelinating Polyneuropathy
- What is being tested?
- Intravenous immune globulin G and Subcutaneous immune globulin G
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2022to 1 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutgers, The State University of New Jersey Clinical Research Center
New Brunswick, New Jersey, 08901
Luigi Brunetti, PhD, 9085952645, luigi.brunetti@rutgers.edu
About this study
Official title: The Influence of Body Composition on Immunoglobulin Disposition After Intravenous and Subcutaneous Administration
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.
Read the 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.
- Being tested
- Intravenous immune globulin G, Subcutaneous immune globulin G
- Keywords
- immunoglobulin, pharmacokinetics, obesity
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Agammaglobulinemia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous immune globulin GDrug
Also called Privigen, IVIG
Intravenous immune globulin G dosed based on the subjects's current dose received for the treatment of CIDP.
Subcutaneous immune globulin GDrug
Also called Hizentra, SCIG
Subcutaneous immune globulin G converted from the subject's current IVIG dose 1:1.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous immune globulin G | Experimental | Subjects will receive there current intravenous immune globulin dose. Receives: Drug: Intravenous immune globulin G |
| Subcutaneous immune globulin G | Experimental | The dosage will be converted from the subject's current intravenous immune globulin G dosage 1:1 (gm per gm). Receives: Drug: Subcutaneous immune globulin G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of drug half-life
Calculation of drug half-life based on data obtained from serum samples
Measured: Through study completion, an average of 4 weeks
Assessment of immune globulin G serum concentration after intravenous immune globulin G administration
Serum IgG concentration (including subtype) will be measured using a human IgG ELISA kit
Measured: 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
Serum IgG concentration (including subtype) will be measured using a human IgG ELISA kit
Measured: Just before drug administration, immediately after drug administration, approximately days 2, 4 and 7 post drug administration
Secondary outcomes (4)
Assessment of grip strength
Grip strength will be measured using the handheld Martin Vigorimeter just before each dose of IgG is administered during the study period. Subjects will be asked to squeeze the dynamometer as hard as possible with each of his or her hands in a standing position.
Measured: Baseline and just before administration of next immune globulin dose.
Assessment of muscle function
The Medical Research Council (MRC) system for testing and grading of muscle function aims to provide a standardized and objective way to assess muscle function. It was originally introduced in 1943 and has a long history of use in neurology, rehabilitation and general medicine examinations. Assessments of muscles are done bilaterally, meaning that for each muscle tested, the same muscle on the opposite side of the body is also tested. The MRC sum score is finally calculated by adding the score of each individually assessed muscle. The MRC score ranges from 0 - 30 with 0 as the worst outcome.
Measured: Baseline and just before administration of next immune globulin dose.
Assessment of patient disability
The Rasch Overall Disability scale (I-RODS) and the Inflammatory Neuropathy Cause and Treatment Sensory (INCAT) sum score disability scale will be completed before the infusion of IgG. The I-RODS score can range from 0 to 48 with 0 representing the greatest disability. The INCAT score ranges from 0 - 10 with 10 representing worse outcome.
Measured: Baseline and just before administration of next immune globulin dose.
Assessment of fatigue
Fatigue is a common patient concern in CIDP and the Rasch-built fatigue severity scale (R-FSS) will be completed before the infusion of IgG. The R-FSS ranges from 9 to 63 with 63 being the worst score
Measured: Baseline and just before administration of next immune globulin dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start11 Sep 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIDPStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Brunetti, Rutgers, The State University of New Jersey
- Investigators
- Luigi Brunetti, PhD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584631
- Sponsor's protocol ID
- Pro2019001038
- Status last verified
- Dec 2025
- First submitted
- 10 Oct 2022
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Body Composition on Immunoglobulin Disposition After Intravenous and Subcutaneous Administration
- ClinicalTrials.gov ID
- NCT05584631
- Acronym / sponsor ID
- Pro2019001038
- Keywords
- immunoglobulin, pharmacokinetics, obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 11 Sep 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous immune globulin G | Experimental | Drug: Intravenous immune globulin GSubjects will receive there current intravenous immune globulin dose. |
| Subcutaneous immune globulin G | Experimental | Drug: Subcutaneous immune globulin GThe dosage will be converted from the subject's current intravenous immune globulin G dosage 1:1 (gm per gm). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous immune globulin GAlso: Privigen, IVIGIntravenous immune globulin G dosed based on the subjects's current dose received for the treatment of CIDP. | Drug | Intravenous immune globulin G |
| Subcutaneous immune globulin GAlso: Hizentra, SCIGSubcutaneous immune globulin G converted from the subject's current IVIG dose 1:1. | Drug | Subcutaneous immune globulin G |
Primary outcome
Assessment of drug half-life
Time frame: Through study completion, an average of 4 weeks
Calculation of drug half-life based on data obtained from serum samples
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
Serum IgG concentration (including subtype) will be measured using a human IgG ELISA kit
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
Serum IgG concentration (including subtype) will be measured using a human IgG ELISA kit
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luigi Brunetti, PhD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intravenous immune globulin G and Subcutaneous immune globulin G in people with CIDP and Immunoglobulin Deficiency, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luigi Brunetti, PhD (2016385868, brunetti@pharmacy.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of drug half-life (time frame: Through study completion, an average of 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.