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NCT01361178 · ClinicalTrials.gov registry record · NA
Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement
A NA study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 133
- Enrollment target
NCT01361178 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 133 participants.
The verdict
NCT01361178, a NA study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 133 participants
- Enrollment target
Study 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
Interventions
- DRUG SQ IVIG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2011-01 |
| Est. Completion | 2016-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01361178
The ClinicalTrials.gov registry entry for NCT01361178 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SQ IVIG is the first listed.
NCT01361178 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01361178 about?
NCT01361178 is a clinical study titled "Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement". 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 ...
What is the current status of trial NCT01361178?
This trial is currently completed. It is a NA study. The enrollment target is 133 participants. The study started on 2011-01. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01361178?
The interventions under investigation include: SQ IVIG (DRUG).
Who is sponsoring clinical trial NCT01361178?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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