NCT00115778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2005

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
8.6 years until next milestone

Results Posted

Study results publicly available

March 5, 2019

Completed
Last Updated

March 5, 2019

Status Verified

February 1, 2019

Enrollment Period

4.2 years

First QC Date

June 26, 2005

Results QC Date

June 14, 2011

Last Update Submit

February 12, 2019

Conditions

HypogammaglobulinemiaLung Transplantation

Keywords

HypogammaglobulinemiaLung Transplantation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Number of Clinically Diagnosed Viral Infections

    3 month

  • Number of Hospital Admissions

    3 month

  • Number of Antibiotic Initiation

    3 month

  • Number of Clinically Diagnosed Fungal Infection

    3 months

  • Number of Lymphocytic Bronchiolitis

    3 months

Study Arms (2)

First IVIG, then Placebo

EXPERIMENTAL

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: IVIGOther: Placebo

First Placebo, then IVIG

EXPERIMENTAL

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: IVIGOther: Placebo

Interventions

IVIGDRUG

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

Also known as: Immune globulin intravenous, Gamunex, Intravenous immunoglobulin
First IVIG, then PlaceboFirst Placebo, then IVIG
PlaceboOTHER

0.1% Albumin in an equal volume to the investigational product

First IVIG, then PlaceboFirst Placebo, then IVIG

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Lung transplant recipients \> 3 months after transplant surgery
  • Immunoglobulin G (IgG) \< 500 mg/dL
  • Stable medical regimen

You may not qualify if:

  • Acute rejection
  • Active infection
  • Contraindication to IVIG
  • Pregnancy
  • Recent thrombotic event

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Hospital Lung Transplant Program

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 25090414RESULT

MeSH Terms

Conditions

Agammaglobulinemia

Interventions

Immunoglobulins, Intravenousgamma-Globulins

Condition Hierarchy (Ancestors)

Blood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Selim Arcasoy, MD
Organization
Columbia University Medical Cetner
sa2059@columbia.edu
212-305-7771

Study Officials

  • Selim M Arcasoy, M.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dickinson W. Richards, Jr. Professor of Medicine (in Pediatrics) at the Columbia University Medical Center, Dept of Medicine Pulmonary

Study Record Dates

First Submitted

June 26, 2005

First Posted

June 27, 2005

Study Start

June 1, 2005

Primary Completion

August 1, 2009

Study Completion

August 1, 2010

Last Updated

March 5, 2019

Results First Posted

March 5, 2019

Record last verified: 2019-02

Locations

US(1)