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

• ClinicalTrials.gov Identifier: NCT01361178
• Recruitment Status: Completed
• First Posted: May 26, 2011
• Results First Posted: March 22, 2017
• Last Update Posted: March 22, 2017
• Sponsor: University of Pittsburgh
• Collaborator: CSL Behring
• Information provided by (Responsible Party): Andrej Petrov, University of Pittsburgh

Tracking Information

• First Submitted Date: May 13, 2011
• First Posted Date: May 26, 2011
• Results First Submitted Date: February 1, 2017
• Results First Posted Date: March 22, 2017
• Last Update Posted Date: March 22, 2017
• Study Start Date: January 2011
• Actual Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 1, 2017)

The Primary Outcome Will be the Total Number of Days With Pneumonia. [ Time Frame: Up to two years post-transplant ]

The primary outcome for this study will be the total number of days with pneumonia. Pneumonia will be defined by the presence of both clinical and radiographic criteria: fever (temperature ≥ 38oC), cough, dyspnea, purulent expectoration and/or changes in the previous characteristics of respiratory secretions; and chest X-ray or CT scan revealing a new or progressive alveolar or interstitial infiltrate or cavitation that could not be explained by any other noninfectious cause.

• Original Primary Outcome Measures (submitted: May 24, 2011): The primary outcome will be the total number of days with pneumonia. [ Time Frame: Up to two years post-transplant ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement
• Official Title: Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement - Observational Arm

Brief Summary

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

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Infections After Lung Transplant

Intervention

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

Study Arms

• 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.
  Intervention: Drug: SQ IVIG

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 12, 2016): 133
• Original Estimated Enrollment (submitted: May 24, 2011): 100
• Actual Study Completion Date: January 2016
• Actual Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01361178
• Other Study ID Numbers: 09090483
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Andrej Petrov, University of Pittsburgh
• Original Responsible Party: Andrej Petrov, MD, University of Pittsburgh School of Medicine
• Current Study Sponsor: University of Pittsburgh
• Original Study Sponsor: Same as current
• Collaborators: CSL Behring
• Investigators: Not Provided
• PRS Account: University of Pittsburgh
• Verification Date: February 2017