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Intravenous Immunoglobulin (IVIG) in Lung Transplantation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Arcasoy, Selim, M.D..
Recruitment status was:  Active, not recruiting
Columbia University
Grifols Therapeutics Inc.
Information provided by:
Arcasoy, Selim, M.D. Identifier:
First received: June 26, 2005
Last updated: June 18, 2009
Last verified: June 2009
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: IVIG for Acquired Immunodeficiency in Lung Transplant Patients

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Bacterial infections [ Time Frame: 3 month ]

Secondary Outcome Measures:
  • Other infections [ Time Frame: 3 month ]
  • Hospital admissions [ Time Frame: 3 month ]
  • Antibiotic use [ Time Frame: 3 month ]
  • Symptoms [ Time Frame: 3 month ]
  • Side effects [ Time Frame: 3 month ]
  • Pulmonary function [ Time Frame: 3 month ]
  • Rejection [ Time Frame: 3 month ]
  • Mortality [ Time Frame: 3 month ]

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:
    Drug: Intravenous immunoglobulin
    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.


Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00115778

United States, New York
New York Presbyterian Hospital Lung Transplant Program
New York, New York, United States, 10032
Sponsors and Collaborators
Arcasoy, Selim, M.D.
Columbia University
Grifols Therapeutics Inc.
Principal Investigator: Selim M Arcasoy, M.D. Columbia University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Selim Arcasoy, MD, Columbia Unversity Identifier: NCT00115778     History of Changes
Other Study ID Numbers: AAAB0431
Study First Received: June 26, 2005
Last Updated: June 18, 2009

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

Additional relevant MeSH terms:
Blood Protein Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs processed this record on August 22, 2017