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Intravenous Immunoglobulin (IVIG) in Lung Transplantation

Information source: Arcasoy, Selim, M.D.
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogammaglobulinemia; Lung Transplantation

Intervention: Intravenous immunoglobulin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Arcasoy, Selim, M.D.

Official(s) and/or principal investigator(s):
Selim M Arcasoy, M.D., Principal Investigator, Affiliation: Columbia University

Overall contact:
David J Lederer, M.D., M.S., Phone: (212) 305-7771, Email: dl427@columbia.edu

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.

Clinical Details

Official title: IVIG for Acquired Immunodeficiency in Lung Transplant Patients

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: Bacterial infections

Secondary outcome:

Other infections

Hospital admissions

Antibiotic use

Symptoms

Side effects

Pulmonary function

Rejection

Mortality

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.

Eligibility

Minimum age: 12 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Lung transplant recipients >3 months after transplant surgery

- IgG < 500 mg/dL

- Stable medical regimen

Exclusion Criteria:

- Acute rejection

- Active infection

- Contraindication to IVIG

- Pregnancy

- Recent thrombotic event

Locations and Contacts

David J Lederer, M.D., M.S., Phone: (212) 305-7771, Email: dl427@columbia.edu

New York Presbyterian Hospital Lung Transplant Program, New York, New York 10032, United States; Recruiting
David J Lederer, M.D., M.S., Phone: 212-305-7771, Email: dl427@columbia.edu
Debbie Rybak, Phone: 212-305-5836, Email: dr2359@columbia.edu
Selim M. Arcasoy, M.D., Principal Investigator
Joshua R Sonett, M.D., Sub-Investigator
Steven M Kawut, M.D., M.S., Sub-Investigator
Jessie S Wilt, M.D., Sub-Investigator
David J Lederer, M.D., M.S., Sub-Investigator
Additional Information

Starting date: June 2005
Ending date: December 2009
Last updated: May 6, 2008

Page last updated: February 12, 2009

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