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Kidney Transplant RejectionProActiveNCT04091984

The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)

An observational study of Kidney Transplant Rejection, run by Natera, Inc. at 55 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Transplant Rejection
What is being tested?
Prospera
How many people
5,000 participants
Where
55 sitesUnited States
Study dates
6 Nov 2019to 1 Oct 2027
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Approximately 5,000 adult renal allograft participants will be enrolled in this study, and data will be collected from a de-identified cohort of approximately 500 historical control patients who had a renal allograft.

Who may be able to join

  • 18 years of age or older
  • 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
  • A genetically different donor (not an identical twin)
  • Selected by a healthcare provider to receive Prospera dd-cfDNA test according to the regular interval testing schedule as part of their practical care
  • Able to read, understand and provide written informed consent
  • Willing and able to comply with the study visit schedule and study requirements
Show all 10Show fewer
  • 18 years of age or older at the time of transplant
  • Had a renal allograft
  • Had a genetically different donor
  • Had a minimum of three evaluations per year during the three years since the renal allograft or until allograft failure

Who cannot join

  • Pregnant
  • 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.
  • History of another organ transplant (i.e. aside from renal allograph)
  • A serious medical condition that may adversely affect ability to participate in the study (e.g, dementia, current diagnosis of cancer)
  • Previously enrolled in the ProActive Registry, with the exception of a graft failure and a new renal allograft
  • Female patients who were pregnant at any time during the 3-year historical control data collection period
  • Had a transplanted organ other than kidney
  • Received results from a dd-cfDNA test designed to assess renal allograft rejection during the historical control data collection period

Trial locations and contacts

55 sites in 1 country.

55 sites in 1 country

United States55 sites

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Colorado

    Aurora, Colorado, 80045

  • University of Maryland

    Baltimore, Maryland, 21201

  • Kidney Care Specialists

    Bethlehem, Pennsylvania, 18017

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Erie County Medical Center

    Buffalo, New York, 14215

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • UT Southwestern

    Dallas, Texas, 75390

  • University of California Davis Medical Center

    Davis, California, 95616

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

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • University of Florida

    Gainesville, Florida, 32611

  • East Carolina University

    Greenville, North Carolina, 27858

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • University of California, Irvine

    Irvine, California, 92697

  • The University of Kansas Medical Center Research Institute

    Kansas City, Kansas, 66160

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Keck School of Medicine USC

    Los Angeles, California, 90033

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

    Los Angeles, California, 90095

  • Northwell Health, Inc

    Manhasset, New York, 11030

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Vanderbilt University

    Nashville, Tennessee, 37235

  • Yale University, School of Medicine

    New Haven, Connecticut, 06520

  • Columbia University Medical Center

    New York, New York, 10032

  • University of Nebraska

    Omaha, Nebraska, 68198

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Arizona Kidney Disease & Hypertension Centers

    Phoenix, Arizona, 85016

  • Legacy Research

    Portland, Oregon, 97232

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Riverside Community Hospital

    Riverside, California, 92501

  • IHC Health Services, Inc

    Salt Lake City, Utah, 84111

  • University of Utah

    Salt Lake City, Utah, 84132

  • California Institute of Renal Research

    San Diego, California, 92123

  • Arizona Kidney Disease & Hypertension Centers

    Scottsdale, Arizona, 85258

  • University of Washington

    Seattle, Washington, 98195

  • Renal Transplant Associates of New England

    Springfield, Massachusetts, 01107

  • St. Louis University

    St Louis, Missouri, 63103

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110

  • Florida Health Sciences Center

    Tampa, Florida, 33606

  • Baylor Scott and White Research Institute

    Temple, Texas, 76508

  • The University of Toledo

    Toledo, Ohio, 43606

  • Arizona Kidney Disease and Hypertension Centers

    Tucson, Arizona, 85712

  • Arizona Kidney Disease & Hypertension Centers

    Tucson, Arizona, 85718

  • Banner University Medical Center

    Tucson, Arizona, 85719

  • The Research Institute at Westchester Medical Center

    Valhalla, New York, 10595

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20057

  • Cleveland Clinic Florida (Weston)

    Weston, Florida, 33331

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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.

Read the detailed 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
Being tested
Prospera
Keywords
donor-derived cfDNA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProsperaDiagnostic test

    No Interventions, this is an observational study.

Study groups in NCT04091984
Study groupRoleWhat they receive
Prospera ArmThere is no intervention in this study. Adult patients who have received a kidney allograft from a genetically different donor in the past 2 years including within 60 days and who have been selected by their healthcare provider to receive Prospera dd-cfDNA testing according to their regular interval testing schedule as part of their clinical care will have medical records pertaining to their kidney rejection status collected at each study visit.
Receives: Diagnostic Test: Prospera
Control ArmThe control arm will consist of retrospective data review of cases where a renal allograft from a genetically different donor was performed. Data pertaining to to their kidney rejection status from a minimum of 3 time points per year post allograft (up to 5 years) or until renal allograft failure will be collected.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficiency of biopsies

    The proportion of clinically indicated biopsies that show Active Rejection (AR) will be measured in the Prospera arm and the control arm. Specifically, the proportion of clinically indicated biopsies showing AR in individuals with a positive donor derived-cell free DNA dd-cfDNA test at the time of Bx in the test arm, where Prospera has been integrated into the care paradigm, will be compared against the proportion of clinically indicated biopsies showing AR in the control arm.

    Measured: 3 years

  2. Graft function

    Graft function in the Prospera arm and control arm will be measured. This will be assessed by examining the average eGFR score (as calculated using serum creatinine Chronic Kidney Disease-EPIdemiology collaboration CKD_EPI equation) at year three in the Prospera arm compared to the average eGFR score determined at year three in the historical control arm.

    Measured: 3 years

Secondary outcomes (3)

  1. Evaluate the performance of Prospera

    The performance of Prospera to detect AR will be evaluated. The sensitivity, specificity, Positive \& Negative Predictive Value of the assay in sub-cohorts of patients will be calculated and compared to the performance of serum creatinine to detect AR in those cohorts.

    Measured: 5 years

  2. Evaluate whether Prospera can detect acute rejection earlier than serum creatinine

    The grade of rejection observed in biopsies in the Prospera arm will be compared to the historical control arm which used serum creatinine.

    Measured: 3 years

  3. Determine if and how Prospera testing impacts patient care

    The proportion of Prospera assay results that doctors felt influenced their decisions around management of patients and biopsies will be calculated. This will be analyzed separately for the for-cause and protocol biopsies.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2019
  2. Study start6 Nov 2019
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Other
Enrolment
5,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04091984
Sponsor's protocol ID
18-039-TRP
Other IDs
Pro00037470
Acronym
ProActive
Status last verified
Jul 2024
First submitted
6 Sep 2019
Last updated
6 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bromberg JS, Bunnapradist S, Samaniego-Picota M, Anand S, Stites E, Gauthier P, Demko Z, Prewett A, Armer-Cabral M, Marshall K, Kaur N, Bloom MS, Tabriziani H, Bhorade S, Cooper M; ProActive Investigators. Elevation of Donor-derived Cell-free DNA Before Biopsy-proven Rejection in Kidney Transplant. Transplantation. 2024 Sep 1;108(9):1994-2004. doi: 10.1097/TP.0000000000005007. Epub 2024 Aug 20.

    PubMed 38595232

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Transplant Rejection, run by Natera, Inc. at 55 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficiency of biopsies (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04091984, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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