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History of Changes for Study: NCT01361178
Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement
Latest version (submitted February 1, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 24, 2011 None (earliest Version on record)
2 December 16, 2014 Recruitment Status, Sponsor/Collaborators, Study Status and Contacts/Locations
3 January 12, 2016 Recruitment Status, Study Status and Study Design
4 February 1, 2017 Study Status, Outcome Measures and Results
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Study NCT01361178
Submitted Date:  May 24, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: 09090483
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
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2011
Overall Status: Recruiting
Study Start: January 2011
Primary Completion: January 2014 [Anticipated]
Study Completion: January 2015 [Anticipated]
First Submitted: May 13, 2011
First Submitted that
Met QC Criteria:
May 24, 2011
First Posted: May 26, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 24, 2011
Last Update Posted: May 26, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Pittsburgh
Responsible Party:
Collaborators: CSL Behring
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module 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
Detailed Description:
Open or close this module Conditions
Conditions: Infections After Lung Transplant
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The primary outcome will be the total number of days with pneumonia.
[ Time Frame: Up to two years post-transplant ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Locations: United States, Pennsylvania
UPMC Comprehensive Lung Center
[Recruiting]
Pittsburgh, Pennsylvania, United States, 15213
Contact:Contact: Petrov petrovaa@upmc.edu
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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