Recruiting
Phase 1

Immunoglobulin G

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05584631

Conditions

CIDP

Immunoglobulin Deficiency

Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Intravenous immune globulin G

Subcutaneous immune globulin G

Study Details

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.

Conditions

CIDP

Immunoglobulin Deficiency

Chronic Inflammatory Demyelinating Polyneuropathy

Study ID

NCT05584631

Start date

Sep 11, 2022

Status verified date

Dec, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Intravenous immune globulin G

Subjects will receive there current intravenous immune globulin dose.

experimental: Subcutaneous immune globulin G

The dosage will be converted from the subject's current intravenous immune globulin G dosage 1:1 (gm per gm).

Interventions

Intravenous immune globulin G

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

Subcutaneous immune globulin G

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Luigi Brunetti, PhD

2016385868brunetti@pharmacy.rutgers.edu

Locations

Rutgers, The State University of New Jersey Clinical Research Center

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Luigi Brunetti, PhD

9085952645luigi.brunetti@rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Keywords

  • immunoglobulin
  • pharmacokinetics
  • obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2025-12-11.