Intravenous Immunoglobulin (IVIG) in Lung Transplantation

Columbia University11 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Hypogammaglobulinemia Lung Transplantation

Interventions

IVIGDRUG

10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks

PlaceboOTHER

0.1% Albumin in an equal volume to the investigational product

Eligibility

Sex: ALLMin age: 12 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

New York Presbyterian Hospital Lung Transplant Program

New York, New York, United States

Outcomes

Primary Outcomes

Number of Clinically Diagnosed Bacterial Infections During the Treatment Period

The number of events occurring during the treatment period. The data will be presented by the occurrence during the IVIG vs. the placebo treatment period, regardless of the order that the treatment was received. Only the clinically diagnosed bacterial infections will be counted.

Time frame: 3 month

Secondary Outcomes

Number of Clinically Diagnosed Viral Infections

This is to measure the effect of IVIG on viral infections.

Time frame: 3 month

Number of Hospital Admissions

This is to measure the effect of IVIG on hospitalizations.

Time frame: 3 month

Number of Antibiotic Initiation

This is to measure the effect of IVIG on the use of antibiotics.

Time frame: 3 month

Number of Clinically Diagnosed Fungal Infection

This is to measure the effect of IVIG on fungal infections.

Time frame: 3 months

Number of Lymphocytic Bronchiolitis

This is to measure the effect of IVIG on lung function.

Time frame: 3 months

Data from ClinicalTrials.gov

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