The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)

NCT04091984 | Active Not Recruiting

• 2 other identifiers: 18-039-TRPPro00037470
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 55

Brief 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.

Conditions

Kidney Transplant Rejection

Keywords

donor-derived cfDNA

Outcome Measures

Primary Outcomes (2)

• 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.

  3 years

• 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.

  3 years

Secondary Outcomes (3)

• Evaluate the performance of Prospera

  5 years

• Evaluate whether Prospera can detect acute rejection earlier than serum creatinine

  3 years

• Determine if and how Prospera testing impacts patient care

  5 years

Study Arms (2)

Prospera Arm

There 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.

Diagnostic Test: Prospera

Control Arm

The 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.

Interventions

Prospera DIAGNOSTIC_TEST

No Interventions, this is an observational study.

Prospera Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Natera, Inc.: lead
• University of Maryland: collaborator

Study Sites (55)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Arizona Kidney Disease & Hypertension Centers

Phoenix, Arizona, 85016, United States

Location

Arizona Kidney Disease & Hypertension Centers

Scottsdale, Arizona, 85258, United States

Location

Arizona Kidney Disease and Hypertension Centers

Tucson, Arizona, 85712, United States

Location

Arizona Kidney Disease & Hypertension Centers

Tucson, Arizona, 85718, United States

Location

Banner University Medical Center

Tucson, Arizona, 85719, United States

Location

University of California Davis Medical Center

Davis, California, 95616, United States

Location

University of California, Irvine

Irvine, California, 92697, United States

Location

Keck School of Medicine USC

Los Angeles, California, 90033, United States

Location

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

Los Angeles, California, 90095, United States

Location

Riverside Community Hospital

Riverside, California, 92501, United States

Location

California Institute of Renal Research

San Diego, California, 92123, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Yale University, School of Medicine

New Haven, Connecticut, 06520, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20057, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Florida Health Sciences Center

Tampa, Florida, 33606, United States

Location

Cleveland Clinic Florida (Weston)

Weston, Florida, 33331, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

The University of Kansas Medical Center Research Institute

Kansas City, Kansas, 66160, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Renal Transplant Associates of New England

Springfield, Massachusetts, 01107, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Harper University Hospital, Detroit Medical Center, Wayne State University

Detroit, Michigan, 48201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

St. Louis University

St Louis, Missouri, 63103, United States

Location

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

Location

University of Nebraska

Omaha, Nebraska, 68198, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

Northwell Health, Inc

Manhasset, New York, 11030, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

The Research Institute at Westchester Medical Center

Valhalla, New York, 10595, United States

Location

East Carolina University

Greenville, North Carolina, 27858, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The University of Toledo

Toledo, Ohio, 43606, United States

Location

Legacy Research

Portland, Oregon, 97232, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Kidney Care Specialists

Bethlehem, Pennsylvania, 18017, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Baylor Scott and White Research Institute

Temple, Texas, 76508, United States

Location

IHC Health Services, Inc

Salt Lake City, Utah, 84111, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

• 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.

  PMID: 38595232 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

There are two arms to this study: A prospective arm and a historical control (retrospective arm). Each participant in the Prospective arm will have received the commercially available Prospera test. Subjects prospectively enrolled and whom consent to "Optional future Research" may have bio-specimens stored for future research. The historical arm (retrospective cohort) will not have any bio-specimens collected or stored.

Study Officials

• Jonathan Bromberg, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 17, 2019
• Study Start: November 6, 2019
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (55)