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

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
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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.
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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
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 ]

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  Serious Adverse Events

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  Other Adverse Events

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  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
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