Intravenous Immunoglobulin (IVIG) in Lung Transplantation

Phase 2

Completed

• Conditions: Lung Transplantation; Hypogammaglobulinemia
• Interventions: Drug: IVIG; Other: Placebo

• Registration Number: NCT00115778
• Lead Sponsor: Columbia University

Brief Summary

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

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 Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-06-26
• Study First Submitted QC: 2005-06-26
• Study First Posted: 2005-06-27
• Primary Completion: 2009-08
• Study Completion: 2010-08
• Results First Submitted: 2011-06-14
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-12
• Last Update Submitted: 2019-02-12
• Results First Posted: 2019-03-05
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First IVIG, then Placebo	IVIG	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.
First IVIG, then Placebo	Placebo	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.
First Placebo, then IVIG	Placebo	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.
First Placebo, then IVIG	IVIG	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.

Primary Outcome Measures

Name	Time	Method
Number of Clinically Diagnosed Bacterial Infections During the Treatment Period	3 month	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

New York Presbyterian Hospital Lung Transplant Program; 🇺🇸 New York, New York, United States