Intravenous Immunoglobulin (IVIG) in Lung Transplantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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IVIG for Acquired Immunodeficiency in Lung Transplant Patients

Conditions
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Hypogammaglobulinemia, Lung Transplantation

Intervention / Treatment
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* Drug: IVIG
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First IVIG, then Placebo<br>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. | Drug: IVIG<br>* 10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks<br>* Other names: Intravenous immunoglobulin;Other: Placebo<br>* 0.1% Albumin in an equal volume to the investigational product<br>|
| Experimental: First Placebo, then IVIG<br>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. | Drug: IVIG<br>* 10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks<br>* Other names: Intravenous immunoglobulin;Other: Placebo<br>* 0.1% Albumin in an equal volume to the investigational product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Clinically Diagnosed Viral Infections | This is to measure the effect of IVIG on viral infections. | 3 month | 
| Number of Hospital Admissions | This is to measure the effect of IVIG on hospitalizations. | 3 month | 
| Number of Antibiotic Initiation | This is to measure the effect of IVIG on the use of antibiotics. | 3 month | 
| Number of Clinically Diagnosed Fungal Infection | This is to measure the effect of IVIG on fungal infections. | 3 months | 
| Number of Lymphocytic Bronchiolitis | This is to measure the effect of IVIG on lung function. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypogammaglobulinemia, Lung Transplantation