IVIG vs SCIG for CIDP

Recruiting in Palo Alto (17 mi)

Overseen byLuigi Brunetti, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Rutgers, The State University of New Jersey

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Luigi Brunetti, PhD

Principal Investigator

Rutgers, The State University of New Jersey

Eligibility Criteria

This trial is for adults over 18 with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). They must meet specific diagnostic criteria and have a dosage conversion rate that fits the study's range. People with active cancer, immune or autoimmune diseases, diabetes, myasthenia gravis, or significant liver or kidney issues cannot participate.

Inclusion Criteria

I am over 18 and have been diagnosed with CIDP.

My weekly dose for SCIG is between 0.2 and 0.4 mg/kg.

Exclusion Criteria

I am not receiving IVIG for conditions other than CIDP.

I have a weakened immune system.

My liver and kidney functions are within normal ranges.

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Treatment Details

Interventions

Intravenous immune globulin G (Immunomodulator)
Subcutaneous immune globulin G (Immunomodulator)

Trial OverviewThe study compares two ways of giving immunoglobulin G (IgG) to CIDP patients: through the veins (IVIG) and under the skin (SCIG). It aims to see how body composition affects these methods in people with different body weights.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Subcutaneous immune globulin GExperimental Treatment1 Intervention

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

Group II: Intravenous immune globulin GExperimental Treatment1 Intervention

Subjects will receive there current intravenous immune globulin dose.