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Intravenous Immunoglobulin (IVIG) in Lung Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Arcasoy, Selim, M.D..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Columbia University
Grifols Therapeutics Inc.
Information provided by:
Arcasoy, Selim, M.D.
ClinicalTrials.gov Identifier:
NCT00115778
First received: June 26, 2005
Last updated: June 18, 2009
Last verified: June 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: IVIG for Acquired Immunodeficiency in Lung Transplant Patients

Resource links provided by NLM:

U.S. FDA Resources

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:
    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

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

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

No publications provided

Responsible Party: Selim Arcasoy, MD, Columbia Unversity
ClinicalTrials.gov Identifier: NCT00115778     History of Changes
Other Study ID Numbers: AAAB0431
Study First Received: June 26, 2005
Last Updated: June 18, 2009
Health Authority: United States: Institutional Review Board

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
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013