Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement
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ClinicalTrials.gov Identifier: NCT01361178 |
Recruitment Status :
Completed
First Posted : May 26, 2011
Results First Posted : March 22, 2017
Last Update Posted : March 22, 2017
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Tracking Information | |||
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First Submitted Date ICMJE | May 13, 2011 | ||
First Posted Date ICMJE | May 26, 2011 | ||
Results First Submitted Date ICMJE | February 1, 2017 | ||
Results First Posted Date ICMJE | March 22, 2017 | ||
Last Update Posted Date | March 22, 2017 | ||
Study Start Date ICMJE | January 2011 | ||
Actual Primary Completion Date | January 2016 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
The primary outcome will be the total number of days with pneumonia. [ Time Frame: Up to two years post-transplant ] | ||
Change History | |||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement | ||
Official Title ICMJE | Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement - Observational Arm | ||
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:
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Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Not Applicable | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Infections After Lung Transplant | ||
Intervention ICMJE | 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
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
133 | ||
Original Estimated Enrollment ICMJE |
100 | ||
Actual Study Completion Date ICMJE | January 2016 | ||
Actual Primary Completion Date | January 2016 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01361178 | ||
Other Study ID Numbers ICMJE | 09090483 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | Andrej Petrov, University of Pittsburgh | ||
Original Responsible Party | Andrej Petrov, MD, University of Pittsburgh School of Medicine | ||
Current Study Sponsor ICMJE | University of Pittsburgh | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | CSL Behring | ||
Investigators ICMJE | Not Provided | ||
PRS Account | University of Pittsburgh | ||
Verification Date | February 2017 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |