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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Sponsor:
University of Pittsburgh
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Andrej Petrov, University of Pittsburgh
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Infections After Lung Transplant |
Intervention |
Drug: SQ IVIG |
Enrollment | 133 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Transplant Patients Who do Not Receive SQ IVIG | Transplant Patients Who Receive SQ IVIG |
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Patients participating in the observational arm of the study who do not need to receive IgG replacement. |
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 |
Period Title: Overall Study | ||
Started | 122 | 11 |
Completed | 109 | 11 |
Not Completed | 13 | 0 |
Reason Not Completed | ||
Death | 13 | 0 |
Baseline Characteristics
Arm/Group Title | Transplant Patients Who do Not Receive SQ IVIG | Transplant Patients Who Receive SQ IVIG | Total | |
---|---|---|---|---|
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Patients participating in the observational arm of the study who do not need to receive IgG replacement. |
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 |
Total of all reporting groups | |
Overall Number of Baseline Participants | 122 | 11 | 133 | |
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[Not Specified]
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 122 participants | 11 participants | 133 participants | |
62
(18 to 75)
|
52
(26 to 70)
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61
(18 to 75)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 122 participants | 11 participants | 133 participants | |
Female |
46 37.7%
|
5 45.5%
|
51 38.3%
|
|
Male |
76 62.3%
|
6 54.5%
|
82 61.7%
|
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 122 participants | 11 participants | 133 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
1 0.8%
|
0 0.0%
|
1 0.8%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
8 6.6%
|
0 0.0%
|
8 6.0%
|
|
White |
113 92.6%
|
11 100.0%
|
124 93.2%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Diagnosis
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 122 participants | 11 participants | 133 participants |
IPF |
44 36.1%
|
2 18.2%
|
46 34.6%
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COPD |
37 30.3%
|
3 27.3%
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40 30.1%
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Cystic Fibrosis |
10 8.2%
|
3 27.3%
|
13 9.8%
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Scleroderma |
11 9.0%
|
1 9.1%
|
12 9.0%
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|
Sarcoidosis |
3 2.5%
|
1 9.1%
|
4 3.0%
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Pulmonary Hypertension |
3 2.5%
|
0 0.0%
|
3 2.3%
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Other |
14 11.5%
|
1 9.1%
|
15 11.3%
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Induction Agent
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 122 participants | 11 participants | 133 participants |
Alemtuzamab |
84 68.9%
|
5 45.5%
|
89 66.9%
|
|
Basiliximab |
38 31.1%
|
6 54.5%
|
44 33.1%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Andrej Petrov, MD |
Organization: | University of Pittsburgh |
Phone: | 412-648-6215 |
EMail: | petrovaa@upmc.edu |
Responsible Party: | Andrej Petrov, University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT01361178 |
Other Study ID Numbers: |
09090483 |
First Submitted: | May 13, 2011 |
First Posted: | May 26, 2011 |
Results First Submitted: | February 1, 2017 |
Results First Posted: | March 22, 2017 |
Last Update Posted: | March 22, 2017 |