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Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement

This study has been completed.
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Andrej Petrov, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01361178
First received: May 13, 2011
Last updated: February 1, 2017
Last verified: February 2017
Results First Received: February 1, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Transplant Patients Who do Not Receive SQ IVIG   Transplant Patients Who Receive SQ IVIG
STARTED   122   11 
COMPLETED   109   11 
NOT COMPLETED   13   0 
Death                13                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Transplant Patients Who do Not Receive SQ IVIG   Transplant Patients Who Receive SQ IVIG   Total 
Overall Participants Analyzed 
[Units: Participants]
 122   11   133 
Age 
[Units: Years]
Median (Full Range)
 62 
 (18 to 75) 
 52 
 (26 to 70) 
 61 
 (18 to 75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      46  37.7%      5  45.5%      51  38.3% 
Male      76  62.3%      6  54.5%      82  61.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
IPF   44   2   46 
COPD   37   3   40 
Cystic Fibrosis   10   3   13 
Scleroderma   11   1   12 
Sarcoidosis   3   1   4 
Pulmonary Hypertension   3   0   3 
Other   14   1   15 
Induction Agent 
[Units: Participants]
Count of Participants
     
Alemtuzamab   84   5   89 
Basiliximab   38   6   44 


  Outcome Measures

1.  Primary:   The Primary Outcome Will be the Total Number of Days With Pneumonia.   [ Time Frame: Up to two years post-transplant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Andrej Petrov, MD
Organization: University of Pittsburgh
phone: 412-648-6215
e-mail: petrovaa@upmc.edu



Responsible Party: Andrej Petrov, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01361178     History of Changes
Other Study ID Numbers: 09090483
Study First Received: May 13, 2011
Results First Received: February 1, 2017
Last Updated: February 1, 2017