Intravenous Immunoglobulin (IVIG) in Lung Transplantation

NCT ID: NCT00115778

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2010-08-31

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.

Conditions

Hypogammaglobulinemia; Lung Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

IVIG

Intervention Type: DRUG

10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks

Placebo

Intervention Type: OTHER

0.1% Albumin in an equal volume to the investigational product

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.

Group Type: EXPERIMENTAL

IVIG

Intervention Type: DRUG

10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks

Placebo

Intervention Type: OTHER

0.1% Albumin in an equal volume to the investigational product

Interventions

IVIG

10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks

Intervention Type: DRUG

Placebo

0.1% Albumin in an equal volume to the investigational product

Intervention Type: OTHER

Other Intervention Names

Immune globulin intravenous; Gamunex; Intravenous immunoglobulin

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grifols Therapeutics LLC

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Selim Arcasoy

Dickinson W. Richards, Jr. Professor of Medicine (in Pediatrics) at the Columbia University Medical Center, Dept of Medicine Pulmonary

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selim M Arcasoy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

New York Presbyterian Hospital Lung Transplant Program

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 25090414 (View on PubMed)

Other Identifiers

AAAB0431

Identifier Type: -

Identifier Source: org_study_id