Overview

This trial is active, not recruiting.

Conditions hypogammaglobulinemia, lung transplantation
Treatment intravenous immunoglobulin
Phase phase 2
Sponsor Arcasoy, Selim, M.D.
Collaborator Columbia University
Start date June 2005
End date November 2009
Trial size 10 participants
Trial identifier NCT00115778, AAAB0431

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention

Primary Outcomes

Measure
Bacterial infections
time frame: 3 month

Secondary Outcomes

Measure
Other infections
time frame: 3 month
Hospital admissions
time frame: 3 month
Antibiotic use
time frame: 3 month
Symptoms
time frame: 3 month
Side effects
time frame: 3 month
Pulmonary function
time frame: 3 month
Rejection
time frame: 3 month
Mortality
time frame: 3 month

Eligibility Criteria

Male or female participants from 12 years up to 75 years old.

Inclusion Criteria: - Lung transplant recipients >3 months after transplant surgery - IgG < 500 mg/dL - Stable medical regimen Exclusion Criteria: - Acute rejection - Active infection - Contraindication to IVIG - Pregnancy - Recent thrombotic event

Additional Information

Official title IVIG for Acquired Immunodeficiency in Lung Transplant Patients
Principal investigator Selim M Arcasoy, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2009.
Information provided to ClinicalTrials.gov by Arcasoy, Selim, M.D..