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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2011 by University of Pittsburgh
Sponsor:
Collaborator:
CSL Behring
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01361178
First received: May 13, 2011
Last updated: May 24, 2011
Last verified: May 2011
  Purpose

Immunosuppressive therapies have led to remarkable improvements in survival in lung transplantation (LT) patients. However, one important adverse effect of these therapies has been the increasing emergence of hypogammaglobulinemia (HGG) which has been previously seen mostly in patients with primary immunodeficiency (PID).

The goal of treatment of HGG in PID has been to maintain the trough IgG level above 500 mg/dl which might provide better protection against infections than do lower IgG serum concentrations. Although IgG therapy is of substantial benefit, the doses and trough levels of IgG that are optimal are not yet clearly established. The impact of high versus low IgG dosing on the frequency and severity of infections and rejection has not been studied before in LT patients with HGG. The specific aims for this study are to compare the incidence of infections in lung transplant recipients receiving higher versus lower dose of SQ IgG and to compare the incidence of infections in lung transplant recipients with mild hypogammaglobulinemia versus normal IgG levels. This study will be a single center study of all lung transplant recipients, age 18 years or older, at the University of Pittsburgh Medical Center (UPMC), with a randomized treatment arm and an observational arm.

The hypotheses for the research study are:

  • Therapy with IV or SQ IgG is of substantial benefit in reducing the number of infections in lung transplant recipients with severe hypogammaglobulinemia (IgG < 500)
  • A higher dose of SQ IgG, with subsequent higher trough IgG levels, may have a higher impact on the frequency and severity of infections and rejection episodes, compared to a lower dose of SQ IgG, with subsequent lower IgG trough levels
  • Lung transplant recipients with mild hypogammaglobulinemia ( IgG= 500-750) have a higher incidence of infections compared to patients with normal IgG levels

Condition Intervention
Infections After Lung Transplant
Drug: SQ IVIG

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement - Observational Arm

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • The primary outcome will be the total number of days with pneumonia. [ Time Frame: Up to two years post-transplant ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.
Active Comparator: 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.
Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult recipients of lung transplantation at the University of Pittsburgh Medical Center, who are able to provide written informed consent prior to transplantation or on the day of lung transplant surgery.

Exclusion Criteria:

  • age less than 18 years-old
  • history of anaphylaxis to IVIG
  • subjects already on IV or SQ IgG treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361178

Locations
United States, Pennsylvania
UPMC Comprehensive Lung Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Petrov       petrovaa@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
CSL Behring
  More Information

No publications provided

Responsible Party: Andrej Petrov, MD, University of Pittsburgh School of Medicine
ClinicalTrials.gov Identifier: NCT01361178     History of Changes
Other Study ID Numbers: 09090483
Study First Received: May 13, 2011
Last Updated: May 24, 2011
Health Authority: United States: University of Pittsburgh Research Conduct and Compliance Office.
United States: Institutional Review Board

Additional relevant MeSH terms:
Infection
Communicable Diseases
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014