The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)

Running, not enrolling

Conditions studied: Kidney Transplant Rejection

In brief

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 facts

Study ID

NCT04091984

Run by

Natera, Inc.

People needed

5000

Starts

2019-11-06

Expected to finish

2027-10-01

Last updated by the study team

2024-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• 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 Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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