Intravenous Immunoglobulin (IVIG) in Lung Transplantation

Lung Transplantation Clinical Trial

Official title:

IVIG for Acquired Immunodeficiency in Lung Transplant Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115778
• Other study ID #: AAAB0431
• Status: Completed
• Phase: Phase 2
• Start date: June 2005
• Est. completion date: August 2010

Study information

• Verified date: February 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Agammaglobulinemia
• Hypogammaglobulinemia
• Lung Transplantation

Intervention

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

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital Lung Transplant Program	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Grifols Therapeutics LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lederer DJ, Philip N, Rybak D, Arcasoy SM, Kawut SM. Intravenous immunoglobulin for hypogammaglobulinemia after lung transplantation: a randomized crossover trial. PLoS One. 2014 Aug 4;9(8):e103908. doi: 10.1371/journal.pone.0103908. eCollection 2014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Clinically Diagnosed Viral Infections	This is to measure the effect of IVIG on viral infections.	3 month
Secondary	Number of Hospital Admissions	This is to measure the effect of IVIG on hospitalizations.	3 month
Secondary	Number of Antibiotic Initiation	This is to measure the effect of IVIG on the use of antibiotics.	3 month
Secondary	Number of Clinically Diagnosed Fungal Infection	This is to measure the effect of IVIG on fungal infections.	3 months
Secondary	Number of Lymphocytic Bronchiolitis	This is to measure the effect of IVIG on lung function.	3 months