NCT00115778

Intravenous Immunoglobulin (IVIG) in Lung Transplantation

IVIG for Acquired Immunodeficiency in Lung Transplant Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypogammaglobulinemia
• Lung Transplantation

Interventions

Type	Name	Description
DRUG	IVIG	10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks
OTHER	Placebo	0.1% Albumin in an equal volume to the investigational product

Timeline

• Start date: 2005-06-01
• Primary completion: 2009-08-01
• Completion: 2010-08-01
• First posted: 2005-06-27
• Last updated: 2019-03-05
• Results posted: 2019-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study