Clinical trial NCT01361178: 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
Overall status: COMPLETED
Phase: NA
Conditions: Infections After Lung Transplant
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: CSL Behring
First posted: 2011-05-26
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: The Primary Outcome Will be the Total Number of Days With Pneumonia.
timeFrame: Up to two years post-transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Comprehensive Lung Center
state: Pennsylvania
Study officials:
References: