Intravenous Immunoglobulin (IVIG) in Lung Transplantation

Columbia University

Status and phase: Completed; Phase 2

Conditions: Hypogammaglobulinemia; Lung Transplantation

Treatments: Drug: IVIG; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00115778

AAAB0431

Details and patient eligibility

About

The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent bacterial infections in lung transplant patients with low serum levels of immunoglobulin.

Full description

An increased risk of infection despite intensive antimicrobial prophylaxis is a well-recognized complication of lung transplantation. Recent evidence suggests that immunosuppressive therapy after solid organ transplantation may lead to humoral immunodeficiency due to hypogammaglobulinemia (HGG). In lung transplant recipients with HGG, IVIG therapy offers the potential to significantly decrease the incidence and severity of infections, thereby reducing morbidity and potentially mortality.

Comparison: The investigators are conducting a randomized clinical trial of IVIG versus placebo for lung transplant patients with severe HGG to see if IVIG decreases the number of bacterial infections in these patients.

Enrollment: 11 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Lung transplant recipients > 3 months after transplant surgery
• Immunoglobulin G (IgG) < 500 mg/dL
• Stable medical regimen

Exclusion criteria

• Acute rejection
• Active infection
• Contraindication to IVIG
• Pregnancy
• Recent thrombotic event

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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11 participants in 2 patient groups

First IVIG, then Placebo

Experimental group

Description:

Study participants will receive three doses of IVIG given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of placebo over 12 weeks.

Treatment:

Drug: IVIG

Other: Placebo

First Placebo, then IVIG

Experimental group

Description:

Study participants will receive three doses of 0.1% albumin solution (placebo) given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of IVIG over 12 weeks.

Treatment:

Drug: IVIG

Other: Placebo