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Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement

This study has been completed.
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Andrej Petrov, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01361178
First received: May 13, 2011
Last updated: February 1, 2017
Last verified: February 2017
History of Changes
May 13, 2011
February 1, 2017
January 2011
January 2016   (Final data collection date for primary outcome measure)
The Primary Outcome Will be the Total Number of Days With Pneumonia. [ Time Frame: Up to two years post-transplant ]
The primary outcome for this study will be the total number of days with pneumonia. Pneumonia will be defined by the presence of both clinical and radiographic criteria: fever (temperature ≥ 38oC), cough, dyspnea, purulent expectoration and/or changes in the previous characteristics of respiratory secretions; and chest X-ray or CT scan revealing a new or progressive alveolar or interstitial infiltrate or cavitation that could not be explained by any other noninfectious cause.
The Primary Outcome Will be the Total Number of Days With Pneumonia. [ Time Frame: Up to two years post-transplant ]
Complete list of historical versions of study NCT01361178 on ClinicalTrials.gov Archive Site
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Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement
Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement - Observational Arm

Immunosuppressive therapies have led to remarkable improvements in survival in lung transplantation (LT) patients. However, one important adverse effect of these therapies has been the increasing emergence of hypogammaglobulinemia (HGG) which has been previously seen mostly in patients with primary immunodeficiency (PID).

The goal of treatment of HGG in PID has been to maintain the trough IgG level above 500 mg/dl which might provide better protection against infections than do lower IgG serum concentrations. Although IgG therapy is of substantial benefit, the doses and trough levels of IgG that are optimal are not yet clearly established. The impact of high versus low IgG dosing on the frequency and severity of infections and rejection has not been studied before in LT patients with HGG. The specific aims for this study are to compare the incidence of infections in lung transplant recipients receiving higher versus lower dose of SQ IgG and to compare the incidence of infections in lung transplant recipients with mild hypogammaglobulinemia versus normal IgG levels. This study will be a single center study of all lung transplant recipients, age 18 years or older, at the University of Pittsburgh Medical Center (UPMC), with a randomized treatment arm and an observational arm.

The hypotheses for the research study are:

  • Therapy with IV or SQ IgG is of substantial benefit in reducing the number of infections in lung transplant recipients with severe hypogammaglobulinemia (IgG < 500)
  • A higher dose of SQ IgG, with subsequent higher trough IgG levels, may have a higher impact on the frequency and severity of infections and rejection episodes, compared to a lower dose of SQ IgG, with subsequent lower IgG trough levels
  • Lung transplant recipients with mild hypogammaglobulinemia ( IgG= 500-750) have a higher incidence of infections compared to patients with normal IgG levels
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Infections After Lung Transplant
Drug: SQ IVIG
Group 1 will receive SQ IgG at the lower end of the dosing range at 100 mg/kg/week and group 2 will receive SQ IgG at the higher end of the dosing range at 200 mg/kg/week
  • No Intervention: Transplant patients who do not receive SQ IVIG
    Patients participating in the observational arm of the study who do not need to receive IgG replacement.
  • Active Comparator: Transplant patients who receive SQ IVIG
    Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.
    Intervention: Drug: SQ IVIG
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
January 2016
January 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult recipients of lung transplantation at the University of Pittsburgh Medical Center, who are able to provide written informed consent prior to transplantation or on the day of lung transplant surgery.

Exclusion Criteria:

  • age less than 18 years-old
  • history of anaphylaxis to IVIG
  • subjects already on IV or SQ IgG treatment
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01361178
09090483
Yes
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Andrej Petrov, University of Pittsburgh
University of Pittsburgh
CSL Behring
Not Provided
University of Pittsburgh
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP