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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
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Andrej Petrov, University of Pittsburgh

Study Type Interventional
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Transplant Patients Who do Not Receive SQ IVIG Transplant Patients Who Receive SQ IVIG
Hide Arm/Group Description 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
Arm/Group Title Transplant Patients Who do Not Receive SQ IVIG Transplant Patients Who Receive SQ IVIG Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 122 participants 11 participants 133 participants
62
(18 to 75)
52
(26 to 70)
61
(18 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
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%
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%
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%
COPD
37
  30.3%
3
  27.3%
40
  30.1%
Cystic Fibrosis
10
   8.2%
3
  27.3%
13
   9.8%
Scleroderma
11
   9.0%
1
   9.1%
12
   9.0%
Sarcoidosis
3
   2.5%
1
   9.1%
4
   3.0%
Pulmonary Hypertension
3
   2.5%
0
   0.0%
3
   2.3%
Other
14
  11.5%
1
   9.1%
15
  11.3%
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%
1.Primary Outcome
Title The Primary Outcome Will be the Total Number of Days With Pneumonia.
Hide Description 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.
Time Frame Up to two years post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transplant Patients Who do Not Receive SQ IVIG Transplant Patients Who Receive SQ IVIG
Hide Arm/Group Description:
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

Overall Number of Participants Analyzed 122 11
Measure Type: Number
Unit of Measure: Number of days
1714 51
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transplant Patients Who do Not Receive SQ IVIG Transplant Patients Who Receive SQ IVIG
Hide Arm/Group Description 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

All-Cause Mortality
Transplant Patients Who do Not Receive SQ IVIG Transplant Patients Who Receive SQ IVIG
Affected / at Risk (%) Affected / at Risk (%)
Total   13/122 (10.66%)   0/11 (0.00%) 
Hide Serious Adverse Events
Transplant Patients Who do Not Receive SQ IVIG Transplant Patients Who Receive SQ IVIG
Affected / at Risk (%) Affected / at Risk (%)
Total   0/122 (0.00%)   0/11 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Transplant Patients Who do Not Receive SQ IVIG Transplant Patients Who Receive SQ IVIG
Affected / at Risk (%) Affected / at Risk (%)
Total   0/122 (0.00%)   0/11 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrej Petrov, MD
Organization: University of Pittsburgh
Phone: 412-648-6215
EMail: petrovaa@upmc.edu
Layout table for additonal information
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