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The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)
Sponsor: Natera, Inc.
Summary
The ProActive registry is a longitudinal, multi-center study with a prospective arm observing clinical care for patients receiving physician ordered Prospera, an allograft rejection test, and a historical control arm collecting data on cases at the same sites whose kidney allograft rejection status was managed with Serum Creatinine SCr/estimated Glomerular Filtration Rate eGFR. This registry will compare patient management and outcomes in patients who receive Prospera (Prospera arm) to the outcomes of the historical control group (control arm) to determine Prospera's clinical utility. High-risk subjects defined as having a biopsy-demonstrated rejection event or at least one pre-existing Donor Specific Antibody DSA with total Mean Fluorescent Intensity MFI\>3000 or a calculated Panel Reactive Antibodies cPRA\>70% will be followed for an additional period up to 24 months in both the Prospera arm and historical control arm.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
5000
Start Date
2019-11-06
Completion Date
2027-10-01
Last Updated
2024-08-06
Healthy Volunteers
No
Conditions
Interventions
Prospera
No Interventions, this is an observational study.
Locations (55)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Kidney Disease & Hypertension Centers
Phoenix, Arizona, United States
Arizona Kidney Disease & Hypertension Centers
Scottsdale, Arizona, United States
Arizona Kidney Disease and Hypertension Centers
Tucson, Arizona, United States
Arizona Kidney Disease & Hypertension Centers
Tucson, Arizona, United States
Banner University Medical Center
Tucson, Arizona, United States
University of California Davis Medical Center
Davis, California, United States
University of California, Irvine
Irvine, California, United States
Keck School of Medicine USC
Los Angeles, California, United States
The Regents of the University of California on behalf of its Los Angeles campus
Los Angeles, California, United States
Riverside Community Hospital
Riverside, California, United States
California Institute of Renal Research
San Diego, California, United States
University of Colorado
Aurora, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale University, School of Medicine
New Haven, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Florida Health Sciences Center
Tampa, Florida, United States
Cleveland Clinic Florida (Weston)
Weston, Florida, United States
Loyola University Medical Center
Maywood, Illinois, United States
The University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
University of Maryland
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Renal Transplant Associates of New England
Springfield, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Harper University Hospital, Detroit Medical Center, Wayne State University
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
St. Louis University
St Louis, Missouri, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Erie County Medical Center
Buffalo, New York, United States
Northwell Health, Inc
Manhasset, New York, United States
Columbia University Medical Center
New York, New York, United States
The Research Institute at Westchester Medical Center
Valhalla, New York, United States
East Carolina University
Greenville, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
The University of Toledo
Toledo, Ohio, United States
Legacy Research
Portland, Oregon, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Kidney Care Specialists
Bethlehem, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Einstein Medical Center
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Vanderbilt University
Nashville, Tennessee, United States
UT Southwestern
Dallas, Texas, United States
Baylor Scott and White Research Institute
Temple, Texas, United States
IHC Health Services, Inc
Salt Lake City, Utah, United States
University of Utah
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
West Virginia University
Morgantown, West Virginia, United States