The purpose of this study is to compare Posoleucel (formerly known as ALVR105; Viralym-M) to placebo in kidney transplant recipients who have high or low levels of BK virus in their blood.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
61
Infusion
Infusion
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs are defined as AEs with a start date and time on or after the first dose of study treatment through the end of study. Clinically significant changes in vital signs, physical exams, laboratory assessments and electrocardiograms were also reported as TEAEs.
Time frame: Day 1 to Week 24
Change From Baseline in BK Viral Load
BK viral load was quantitated using polymerase chain reaction assays at the central laboratory. A negative change from baseline represents a reduction in BK viral load.
Time frame: Baseline and Week 24
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Keck Medical Center of USC
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of California Davis Medical Center
Sacramento, California, United States
University of California, San Francisco Medical Center
San Francisco, California, United States
Piedmont Hospital
Atlanta, Georgia, United States
Northwestern University Transplant Center
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Indiana University Hospital
Indianapolis, Indiana, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
...and 23 more locations