The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)

Last updated: August 2, 2024
Sponsor: Natera, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Prospera

Clinical Study ID

NCT04091984
18-039-TRP
Pro00037470
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria Prospera Arm:

  1. 18 years of age or older

  2. Renal allograft (kidney transplant) up to 2 years prior to signing informed consent. Newly transplanted patients to receive Prospera testing within 60 days of transplant

  3. A genetically different donor (not an identical twin)

  4. Selected by a healthcare provider to receive Prospera dd-cfDNA test according to the regular interval testing schedule as part of their practical care

  5. Able to read, understand and provide written informed consent

  6. Willing and able to comply with the study visit schedule and study requirements

Exclusion Criteria Prospera Arm:

  1. Pregnant

  2. Routine ongoing testing with another dd-cfDNA or RNA biomarker test after enrollment into the ProActive study. Receipt of another dd-cfDNA test within 30 days of a patient being enrolled in the study.

  3. History of another organ transplant (i.e. aside from renal allograph)

  4. A serious medical condition that may adversely affect ability to participate in the study (e.g, dementia, current diagnosis of cancer)

  5. Previously enrolled in the ProActive Registry, with the exception of a graft failure and a new renal allograft

Inclusion Criteria Control Arm:

  1. 18 years of age or older at the time of transplant

  2. Had a renal allograft

  3. Had a genetically different donor

  4. Had a minimum of three evaluations per year during the three years since the renal allograft or until allograft failure

Exclusion Criteria Control Arm:

  1. Female patients who were pregnant at any time during the 3-year historical control data collection period

  2. Had a transplanted organ other than kidney

  3. Received results from a dd-cfDNA test designed to assess renal allograft rejection during the historical control data collection period

Study Design

Total Participants: 5000
Treatment Group(s): 1
Primary Treatment: Prospera
Phase:
Study Start date:
November 06, 2019
Estimated Completion Date:
October 01, 2027

Study Description

The primary objective is to differentiate the clinical utility of Prospera testing from the use of creatinine testing as measured by the proportion of positive biopsies in post renal allograft patients.

Secondary objectives include:

  • To observe the performance of the Prospera assay in detecting AR (repeated validation)

  • To evaluate whether Prospera can detect AR earlier and more often than SCr

  • To determine whether use of Prospera will significant decrease the rate of overall number of biopsies when compared to the rate of biopsies in the control arm

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Arizona Kidney Disease & Hypertension Centers

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Arizona Kidney Disease & Hypertension Centers

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Arizona Kidney Disease & Hypertension Centers

    Tucson, Arizona 85718
    United States

    Site Not Available

  • Arizona Kidney Disease and Hypertension Centers

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Banner University Medical Center

    Tucson, Arizona 85719
    United States

    Site Not Available

  • University of California Davis Medical Center

    Davis, California 95616
    United States

    Site Not Available

  • University of California, Irvine

    Irvine, California 92697
    United States

    Site Not Available

  • Keck School of Medicine USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • The Regents of the University of California on behalf of its Los Angeles campus

    Los Angeles, California 90095
    United States

    Site Not Available

  • Riverside Community Hospital

    Riverside, California 92501
    United States

    Site Not Available

  • California Institute of Renal Research

    San Diego, California 92123
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Hartford Hospital

    Hartford, Connecticut 06102
    United States

    Site Not Available

  • Yale University, School of Medicine

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • George Washington University Hospital

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Georgetown University Medical Center

    Washington, District of Columbia 20057
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32611
    United States

    Site Not Available

  • Florida Health Sciences Center

    Tampa, Florida 33606
    United States

    Site Not Available

  • Cleveland Clinic Florida (Weston)

    Weston, Florida 33331
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • The University of Kansas Medical Center Research Institute

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts 01805
    United States

    Site Not Available

  • Renal Transplant Associates of New England

    Springfield, Massachusetts 01107
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Harper University Hospital, Detroit Medical Center, Wayne State University

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • St. John Hospital and Medical Center

    Detroit, Michigan 48236
    United States

    Site Not Available

  • St. Louis University

    Saint Louis, Missouri 63103
    United States

    Site Not Available

  • Washington University School of Medicine in St. Louis

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • University of Nebraska

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Saint Barnabas Medical Center

    Livingston, New Jersey 07039
    United States

    Site Not Available

  • Erie County Medical Center

    Buffalo, New York 14215
    United States

    Site Not Available

  • Northwell Health, Inc

    Manhasset, New York 11030
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • The Research Institute at Westchester Medical Center

    Valhalla, New York 10595
    United States

    Site Not Available

  • East Carolina University

    Greenville, North Carolina 27858
    United States

    Site Not Available

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • The University of Toledo

    Toledo, Ohio 43606
    United States

    Site Not Available

  • Legacy Research

    Portland, Oregon 97232
    United States

    Site Not Available

  • Lehigh Valley Health Network

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • Kidney Care Specialists

    Bethlehem, Pennsylvania 18017
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • Einstein Medical Center

    Philadelphia, Pennsylvania 19141
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Vanderbilt University

    Nashville, Tennessee 37235
    United States

    Site Not Available

  • UT Southwestern

    Dallas, Texas 75390
    United States

    Site Not Available

  • Baylor Scott and White Research Institute

    Temple, Texas 76508
    United States

    Site Not Available

  • IHC Health Services, Inc

    Salt Lake City, Utah 84111
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

  • West Virginia University

    Morgantown, West Virginia 26506
    United States

    Site Not Available

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