Back to resultsIntravenous Immunoglobulin (IVIG) in Lung Transplantation
Primary Purpose
Hypogammaglobulinemia, Lung Transplantation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IVIG
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hypogammaglobulinemia focused on measuring Hypogammaglobulinemia, Lung Transplantation
Eligibility Criteria
Inclusion Criteria: Lung transplant recipients > 3 months after transplant surgery Immunoglobulin G (IgG) < 500 mg/dL Stable medical regimen Exclusion Criteria: Acute rejection Active infection Contraindication to IVIG Pregnancy Recent thrombotic event
Sites / Locations
- New York Presbyterian Hospital Lung Transplant Program
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
First IVIG, then Placebo
First Placebo, then IVIG
Arm Description
Study participants will receive three doses of IVIG given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of placebo over 12 weeks.
Study participants will receive three doses of 0.1% albumin solution (placebo) given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of IVIG over 12 weeks.
Outcomes
Primary Outcome Measures
Number of Clinically Diagnosed Bacterial Infections During the Treatment Period
The number of events occurring during the treatment period. The data will be presented by the occurrence during the IVIG vs. the placebo treatment period, regardless of the order that the treatment was received. Only the clinically diagnosed bacterial infections will be counted.
Secondary Outcome Measures
Number of Clinically Diagnosed Viral Infections
This is to measure the effect of IVIG on viral infections.
Number of Hospital Admissions
This is to measure the effect of IVIG on hospitalizations.
Number of Antibiotic Initiation
This is to measure the effect of IVIG on the use of antibiotics.
Number of Clinically Diagnosed Fungal Infection
This is to measure the effect of IVIG on fungal infections.
Number of Lymphocytic Bronchiolitis
This is to measure the effect of IVIG on lung function.
Full Information
NCT ID
NCT00115778
First Posted
June 26, 2005
Last Updated
February 12, 2019
Sponsor
Columbia University
Collaborators
Grifols Therapeutics LLC
1. Study Identification
Unique Protocol Identification Number
NCT00115778
Brief Title
Intravenous Immunoglobulin (IVIG) in Lung Transplantation
Official Title
IVIG for Acquired Immunodeficiency in Lung Transplant Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Grifols Therapeutics LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent bacterial infections in lung transplant patients with low serum levels of immunoglobulin.
Detailed Description
An increased risk of infection despite intensive antimicrobial prophylaxis is a well-recognized complication of lung transplantation. Recent evidence suggests that immunosuppressive therapy after solid organ transplantation may lead to humoral immunodeficiency due to hypogammaglobulinemia (HGG). In lung transplant recipients with HGG, IVIG therapy offers the potential to significantly decrease the incidence and severity of infections, thereby reducing morbidity and potentially mortality.
Comparison: The investigators are conducting a randomized clinical trial of IVIG versus placebo for lung transplant patients with severe HGG to see if IVIG decreases the number of bacterial infections in these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogammaglobulinemia, Lung Transplantation
Keywords
Hypogammaglobulinemia, Lung Transplantation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
First IVIG, then Placebo
Arm Type
Experimental
Arm Description
Study participants will receive three doses of IVIG given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of placebo over 12 weeks.
Arm Title
First Placebo, then IVIG
Arm Type
Experimental
Arm Description
Study participants will receive three doses of 0.1% albumin solution (placebo) given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of IVIG over 12 weeks.
Intervention Type
Drug
Intervention Name(s)
IVIG
Other Intervention Name(s)
Immune globulin intravenous, Gamunex, Intravenous immunoglobulin
Intervention Description
10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
0.1% Albumin in an equal volume to the investigational product
Primary Outcome Measure Information:
Title
Number of Clinically Diagnosed Bacterial Infections During the Treatment Period
Description
The number of events occurring during the treatment period. The data will be presented by the occurrence during the IVIG vs. the placebo treatment period, regardless of the order that the treatment was received. Only the clinically diagnosed bacterial infections will be counted.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Number of Clinically Diagnosed Viral Infections
Description
This is to measure the effect of IVIG on viral infections.
Time Frame
3 month
Title
Number of Hospital Admissions
Description
This is to measure the effect of IVIG on hospitalizations.
Time Frame
3 month
Title
Number of Antibiotic Initiation
Description
This is to measure the effect of IVIG on the use of antibiotics.
Time Frame
3 month
Title
Number of Clinically Diagnosed Fungal Infection
Description
This is to measure the effect of IVIG on fungal infections.
Time Frame
3 months
Title
Number of Lymphocytic Bronchiolitis
Description
This is to measure the effect of IVIG on lung function.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Lung transplant recipients > 3 months after transplant surgery
Immunoglobulin G (IgG) < 500 mg/dL
Stable medical regimen
Exclusion Criteria:
Acute rejection
Active infection
Contraindication to IVIG
Pregnancy
Recent thrombotic event
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selim M Arcasoy, M.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Hospital Lung Transplant Program
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25090414
Citation
Lederer DJ, Philip N, Rybak D, Arcasoy SM, Kawut SM. Intravenous immunoglobulin for hypogammaglobulinemia after lung transplantation: a randomized crossover trial. PLoS One. 2014 Aug 4;9(8):e103908. doi: 10.1371/journal.pone.0103908. eCollection 2014.
Results Reference
result
Learn more about this trial
Intravenous Immunoglobulin (IVIG) in Lung Transplantation
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