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

Tracking Information
First Submitted Date ICMJE	May 13, 2011
First Posted Date ICMJE	May 26, 2011
Results First Submitted Date	February 1, 2017
Results First Posted Date	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; (submitted: February 1, 2017)	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.
Original Primary Outcome Measures ICMJE; (submitted: May 24, 2011)	The Primary Outcome Will be the Total Number of Days With Pneumonia. [ Time Frame: Up to two years post-transplant ]
Change History	Complete list of historical versions of study NCT01361178 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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: 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	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
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
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 12, 2016)	133
Original Estimated Enrollment ICMJE; (submitted: May 24, 2011)	100
Actual Study Completion Date	January 2016
Actual Primary Completion Date	January 2016 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	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	Not Provided
Responsible Party	Andrej Petrov, University of Pittsburgh
Study Sponsor ICMJE	University of Pittsburgh
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