Trial Outcomes & Findings for Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement (NCT NCT01361178)
NCT ID: NCT01361178
Last Updated: 2017-03-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
133 participants
Primary outcome timeframe
Up to two years post-transplant
Results posted on
2017-03-22
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
11
|
|
Overall Study
COMPLETED
|
109
|
11
|
|
Overall Study
NOT COMPLETED
|
13
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Death
|
13
|
0
|
Baseline Characteristics
Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement
Baseline characteristics by cohort
| Measure |
Transplant Patients Who do Not Receive SQ IVIG
n=122 Participants
Patients participating in the observational arm of the study who do not need to receive IgG replacement.
|
Transplant Patients Who Receive SQ IVIG
n=11 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
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
52 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
113 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Diagnosis
IPF
|
44 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Diagnosis
COPD
|
37 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Diagnosis
Cystic Fibrosis
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Diagnosis
Scleroderma
|
11 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Diagnosis
Sarcoidosis
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Diagnosis
Pulmonary Hypertension
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Diagnosis
Other
|
14 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Induction Agent
Alemtuzamab
|
84 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Induction Agent
Basiliximab
|
38 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to two years post-transplantThe 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.
Outcome measures
| Measure |
Transplant Patients Who do Not Receive SQ IVIG
n=122 Participants
Patients participating in the observational arm of the study who do not need to receive IgG replacement.
|
Transplant Patients Who Receive SQ IVIG
n=11 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
|
|---|---|---|
|
The Primary Outcome Will be the Total Number of Days With Pneumonia.
|
1714 Number of days
|
51 Number of days
|
Adverse Events
Transplant Patients Who do Not Receive SQ IVIG
Serious events: 0 serious events
Other events: 0 other events
Deaths: 13 deaths
Transplant Patients Who Receive SQ IVIG
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place