IVIG vs SCIG in CIDP

• Status: Recruiting
• Trial end date: 2024-10-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Treatments: Antibodies; gamma-Globulins; Immunoglobulin G; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

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