Intravenous Immunoglobulin (IVIG) in Lung Transplantation - Full Text View

Sponsors and Collaborators:	Arcasoy, Selim, M.D. Columbia University Talecris Biotherapeutics
Information provided by:	Arcasoy, Selim, M.D.
ClinicalTrials.gov Identifier:	NCT00115778

Purpose

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.

Condition	Intervention	Phase
Hypogammaglobulinemia Lung Transplantation	Drug: Intravenous immunoglobulin	Phase II

Genetics Home Reference related topics: aceruloplasminemia X-linked agammaglobulinemia

MedlinePlus related topics: Bacterial Infections Lung Transplantation

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	IVIG for Acquired Immunodeficiency in Lung Transplant Patients

Further study details as provided by Arcasoy, Selim, M.D.:

Primary Outcome Measures:

Bacterial infections [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Other infections [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
Hospital admissions [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
Antibiotic use [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
Symptoms [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
Side effects [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
Pulmonary function [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
Rejection [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
Mortality [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	June 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Intravenous immunoglogbulin 400mg/kg IV monthly

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

Ages Eligible for Study:	12 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115778

Contacts

Contact: David J Lederer, M.D., M.S.

(212) 305-7771

dl427@columbia.edu

Locations

United States, New York
New York Presbyterian Hospital Lung Transplant Program	Recruiting
New York, New York, United States, 10032
Contact: David J Lederer, M.D., M.S. 212-305-7771 dl427@columbia.edu
Contact: Debbie Rybak 212-305-5836 dr2359@columbia.edu
Principal Investigator: Selim M. Arcasoy, M.D.
Sub-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.

Sponsors and Collaborators

Arcasoy, Selim, M.D.

Columbia University

Talecris Biotherapeutics

Investigators

Principal Investigator:

Selim M Arcasoy, M.D.

Columbia University

More Information

Responsible Party:	Columbia Unversity ( Selim Arcasoy, MD )
Study ID Numbers:	AAAB0431
Study First Received:	June 26, 2005
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00115778
Health Authority:	United States: Institutional Review Board

Keywords provided by Arcasoy, Selim, M.D.:

Hypogammaglobulinemia
Lung Transplantation

Study placed in the following topic categories:

Lymphatic Diseases
Antibodies
Agammaglobulinemia
Immunoglobulins, Intravenous
Hematologic Diseases

Blood Protein Disorders
Rho(D) Immune Globulin
Lymphoproliferative Disorders
Immunologic Deficiency Syndromes
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009