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Surveillance HeartCare® Outcomes Registry
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients.
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A Study to Evaluate Posoleucel ALVR105 to Treat Kidney Transplant Recipients with BK Viremia
Scottsdale/Phoenix, AZ
The purpose of this study of posoleucel ALVR105 is to assess the safety and tolerability of posoleucel ALVR105 in kidney transplant recipients. The key secondary objective is to test the hypothesis that the administration of posoleucel ALVR105 to kidney transplant recipients with BK viremia will demonstrate superiority in suppressing BK viral load compared with placebo.
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Iron-Immune System Interaction Shapes Renal Allograft Outcomes After Infections
Scottsdale/Phoenix, AZ
The objectives of this study are to establish the dynamic changes in iron metabolism and circulating iron-regulatory immune cells in kidney transplant infection, and to determine quantitative changes in tissue levels of hepcidin and iron-regulatory macrophages in transplant biopsy and compare pyelonephritis case with control.
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A Multiple Dose Study To Evaluate Safety, Tolerability, PK, And Efficacy Of SER-155 In Adults Undergoing HSCT
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and effectiveness of SER-155 in adults undergoing hematopoietic stem cell transplantation to reduce the risk of infection and graft vs. host disease.
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PC945 Prophylaxis Or Pre-emptive Therapy Against Pulmonary Aspergillosis In Lung Transplant Recipients
Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability of PC945 for the prevention of fungal aspergillus infections in the lung in patients who have received a lung transplant.
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A Study to Evaluate Interferon-gamma in Antifungal Immunity
Rochester, MN
The purpose of this study is to evaluate the role of interferon-gamma (IFN-γ) in antifungal defense and its potential use in adjunctive immunotherapy. Solid organ transplant (SOT) and hematopoietic stem cell transplant (HSCT) recipients are at increased risk for invasive fungal infections. Mortality rates remain unacceptably high despite antifungal treatment. Novel therapeutic modalities are urgently needed. In this project, we propose to study the role of interferon-gamma (IFN-gamma) in antifungal defense and its potential use in adjunctive immunotherapy.
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Study For The Treatment Of Cytomegalovirus (CMV) Infection In Hematopoietic Stem Cell Transplant Recipients
Rochester, MN
The purpose of this study is to compare the efficacy and safety of maribavir to valganciclovir for the treatment of cytomegalovirus (CMV) infection in asymptomatic hematopoietic stem cell transplant recipients.
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Study Of Rezafungin Compared To Standard Antimicrobial Regimen For Prevention Of Invasive Fungal Diseases In Adults Undergoing Allogeneic Blood And Marrow Transplantation (ReSPECT)
Rochester, MN
The primary objective of the United States Food and Drug Administration (FDA) for this study is to demonstrate non-inferiority in subjects who received an allogeneic BMT for subjects randomized to Rezafungin for Injection compared to subjects randomized to the standard antimicrobial regimen (SAR) for fungal-free survival at Day 90 (±7 days).
The primary objective of the European Medicines Agency (EMA) for this study is to demonstrate superiority in subjects who received an allogeneic BMT randomized to Rezafungin for Injection compared to subjects randomized to the SAR for fungal-free survival at Day 90 (±7 days).