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| Name | Class |
|---|---|
| CSL Behring | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transplant patients who do not receive SQ IVIG | No Intervention | Patients participating in the observational arm of the study who do not need to receive IgG replacement. | |
| Transplant patients who receive SQ IVIG | Active Comparator | Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SQ IVIG | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome Will be the Total Number of Days With Pneumonia. | 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. | Up to two years post-transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Comprehensive Lung Center | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Transplant Patients Who Receive SQ IVIG |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Outcome Will be the Total Number of Days With Pneumonia. | 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. | Posted | Number | Number of days | Up to two years post-transplant |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrej Petrov, MD | University of Pittsburgh | 412-648-6215 | petrovaa@upmc.edu |
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Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Diagnosis | Count of Participants | Participants |
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| Induction Agent | Count of Participants | Participants |
|
Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level. 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 |
|
|
| 13 |
| 122 |
| 0 |
| 122 |
| 0 |
| 122 |
| EG001 | 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. 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 | 0 | 11 | 0 | 11 | 0 | 11 |
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