Intravenous Immunoglobulin (IVIG) in Lung Transplantation
Information source: Arcasoy, Selim, M.D.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogammaglobulinemia; Lung Transplantation
Intervention: Intravenous immunoglobulin (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Arcasoy, Selim, M.D.
Official(s) and/or principal investigator(s):
Selim M Arcasoy, M.D., Principal Investigator, Affiliation: Columbia University
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.
Official title: IVIG for Acquired Immunodeficiency in Lung Transplant Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Bacterial infections
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.
Minimum age: 12 Years.
Maximum age: 75 Years.
- Lung transplant recipients >3 months after transplant surgery
- IgG < 500 mg/dL
- Stable medical regimen
- Acute rejection
- Active infection
- Contraindication to IVIG
- Recent thrombotic event
Locations and Contacts
New York Presbyterian Hospital Lung Transplant Program, New York, New York 10032, United States
Starting date: June 2005
Last updated: June 18, 2009