Skip to main content
OpenTrials
Completed

NCT Number: NCT00115778

Intravenous Immunoglobulin (IVIG) in Lung Transplantation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypogammaglobulinemia Agammaglobulinemia Blood Protein Disorders Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunologic Deficiency Syndromes Lung Transplantation Lymphatic Diseases Lymphoproliferative Disorders

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York Presbyterian Hospital Lung Transplant Program

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Lung transplant recipients > 3 months after transplant surgery
  • Immunoglobulin G (IgG) < 500 mg/dL
  • Stable medical regimen

Exclusion criteria

  • Acute rejection
  • Active infection
  • Contraindication to IVIG
  • Pregnancy
  • Recent thrombotic event

Treatment and study plan

IVIG

Drug

10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks

Other names: Immune globulin intravenous, Gamunex, Intravenous immunoglobulin

Placebo

Other

0.1% Albumin in an equal volume to the investigational product

Primary outcomes

  1. Number of Clinically Diagnosed Bacterial Infections During the Treatment Period

    Time frame: 3 month

    The number of events occurring during the treatment period. The data will be presented by the occurrence during the IVIG vs. the placebo treatment period, regardless of the order that the treatment was received. Only the clinically diagnosed bacterial infections will be counted.

Secondary outcomes

  1. Number of Clinically Diagnosed Viral Infections

    Time frame: 3 month

    This is to measure the effect of IVIG on viral infections.

  2. Number of Hospital Admissions

    Time frame: 3 month

    This is to measure the effect of IVIG on hospitalizations.

  3. Number of Antibiotic Initiation

    Time frame: 3 month

    This is to measure the effect of IVIG on the use of antibiotics.

  4. Number of Clinically Diagnosed Fungal Infection

    Time frame: 3 months

    This is to measure the effect of IVIG on fungal infections.

  5. Number of Lymphocytic Bronchiolitis

    Time frame: 3 months

    This is to measure the effect of IVIG on lung function.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Grifols Therapeutics LLC

Registry information

Official study title

IVIG for Acquired Immunodeficiency in Lung Transplant Patients

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Jun 27, 2005
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.