Intravenous Immunoglobulin (IVIG) in Lung Transplantation

IVIG for Acquired Immunodeficiency in Lung Transplant Patients

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.

Study Overview

• Status: Completed
• Conditions: Lung Transplantation; Hypogammaglobulinemia
• Intervention / Treatment: Drug: IVIG; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital Lung Transplant Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: First IVIG, then Placebo; 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.	Drug: IVIG; 10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks; Other Names: Intravenous immunoglobulin; Gamunex; Immune globulin intravenous; Other: Placebo; 0.1% Albumin in an equal volume to the investigational product
Experimental: First Placebo, then IVIG; 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.	Drug: IVIG; 10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks; Other Names: Intravenous immunoglobulin; Gamunex; Immune globulin intravenous; Other: Placebo; 0.1% Albumin in an equal volume to the investigational product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Clinically Diagnosed Viral Infections	This is to measure the effect of IVIG on viral infections.	3 month
Number of Hospital Admissions	This is to measure the effect of IVIG on hospitalizations.	3 month
Number of Antibiotic Initiation	This is to measure the effect of IVIG on the use of antibiotics.	3 month
Number of Clinically Diagnosed Fungal Infection	This is to measure the effect of IVIG on fungal infections.	3 months
Number of Lymphocytic Bronchiolitis	This is to measure the effect of IVIG on lung function.	3 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Grifols Therapeutics LLC
• Investigators: Principal Investigator: Selim M Arcasoy, M.D., Columbia University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: June 26, 2005
• First Submitted That Met QC Criteria: June 26, 2005
• First Posted (Estimate): June 27, 2005

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Hypogammaglobulinemia; Lung Transplantation
• Additional Relevant MeSH Terms: Immunologic Deficiency Syndromes; Immune System Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hematologic Diseases; Blood Protein Disorders; Agammaglobulinemia; Physiological Effects of Drugs; Immunologic Factors; Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
• Other Study ID Numbers: AAAB0431

Drug and device information, study documents

• 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