Infections After Lung Transplant Clinical Trial
Official title:
Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement - Observational Arm
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
| Status | Completed |
| Enrollment | 133 |
| Est. completion date | January 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | UPMC Comprehensive Lung Center | Pittsburgh | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| University of Pittsburgh | CSL Behring |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary outcome will be the total number of days with pneumonia. | Up to two years post-transplant | No |