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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00115778
First Posted: June 27, 2005
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Columbia University
Grifols Therapeutics Inc.
Information provided by:
Arcasoy, Selim, M.D.
  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 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00115778


Locations
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.
Investigators
Principal Investigator: Selim M Arcasoy, M.D. Columbia University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Selim Arcasoy, MD, Columbia Unversity
ClinicalTrials.gov Identifier: NCT00115778     History of Changes
Other Study ID Numbers: AAAB0431
First Submitted: June 26, 2005
First Posted: June 27, 2005
Last Update Posted: October 12, 2017
Last Verified: June 2009

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

Additional relevant MeSH terms:
Agammaglobulinemia
Blood Protein Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs