Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement
Primary Purpose
Infections After Lung Transplant
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SQ IVIG
Sponsored by
About this trial
This is an interventional treatment trial for Infections After Lung Transplant
Eligibility Criteria
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
Sites / Locations
- UPMC Comprehensive Lung Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Transplant patients who do not receive SQ IVIG
Transplant patients who receive SQ IVIG
Arm Description
Patients participating in the observational arm of the study who do not need to receive IgG replacement.
Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.
Outcomes
Primary Outcome Measures
The Primary Outcome Will be the Total Number of Days With Pneumonia.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01361178
First Posted
May 13, 2011
Last Updated
February 1, 2017
Sponsor
University of Pittsburgh
Collaborators
CSL Behring
1. Study Identification
Unique Protocol Identification Number
NCT01361178
Brief Title
Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement
Official Title
Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement - Observational Arm
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
CSL Behring
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections After Lung Transplant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transplant patients who do not receive SQ IVIG
Arm Type
No Intervention
Arm Description
Patients participating in the observational arm of the study who do not need to receive IgG replacement.
Arm Title
Transplant patients who receive SQ IVIG
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
SQ IVIG
Intervention Description
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
Primary Outcome Measure Information:
Title
The Primary Outcome Will be the Total Number of Days With Pneumonia.
Description
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.
Time Frame
Up to two years post-transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UPMC Comprehensive Lung Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
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Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement
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