The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)
- Conditions
- Kidney Transplant Rejection
- Interventions
- Diagnostic Test: Prospera
- Registration Number
- NCT04091984
- Lead Sponsor
- Natera, Inc.
- 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.
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 5000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prospera Arm Prospera 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.
- Primary Outcome Measures
Name Time Method Efficiency of biopsies 3 years 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.
Graft function 3 years 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.
- Secondary Outcome Measures
Name Time Method Evaluate the performance of Prospera 5 years 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.
Determine if and how Prospera testing impacts patient care 5 years 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.
Evaluate whether Prospera can detect acute rejection earlier than serum creatinine 3 years The grade of rejection observed in biopsies in the Prospera arm will be compared to the historical control arm which used serum creatinine.
Trial Locations
- Locations (53)
UT Southwestern
🇺🇸Dallas, Texas, United States
Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
California Institute of Renal Research
🇺🇸San Diego, California, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
IHC Health Services, Inc
🇺🇸Salt Lake City, Utah, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Harper University Hospital, Detroit Medical Center, Wayne State University
🇺🇸Detroit, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Legacy Research
🇺🇸Portland, Oregon, United States
University of Nebraska
🇺🇸Omaha, Nebraska, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Florida Health Sciences Center
🇺🇸Tampa, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Arizona Kidney Disease & Hypertension Centers
🇺🇸Tucson, Arizona, United States
Riverside Community Hospital
🇺🇸Riverside, 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
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Saint Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Banner University Medical Center
🇺🇸Tucson, Arizona, United States
The University of Toledo
🇺🇸Toledo, Ohio, United States
Kidney Care Specialists
🇺🇸Bethlehem, Pennsylvania, United States
University of California, Irvine
🇺🇸Irvine, California, United States
Arizona Kidney Disease and Hypertension Centers
🇺🇸Tucson, Arizona, United States
University of California Davis Medical Center
🇺🇸Davis, California, United States
University of Washington
🇺🇸Seattle, Washington, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Erie County Medical Center
🇺🇸Buffalo, New York, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Baylor Scott and White Research Institute
🇺🇸Temple, Texas, United States
Cleveland Clinic Florida (Weston)
🇺🇸Weston, Florida, United States
Washington University School of Medicine in St. Louis
🇺🇸Saint Louis, Missouri, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Renal Transplant Associates of New England
🇺🇸Springfield, Massachusetts, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
The Research Institute at Westchester Medical Center
🇺🇸Valhalla, New York, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Northwell Health, Inc
🇺🇸Manhasset, New York, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Lahey Hospital and Medical Center
🇺🇸Burlington, Massachusetts, United States
The University of Kansas Medical Center Research Institute
🇺🇸Kansas City, Kansas, United States
St. Louis University
🇺🇸Saint Louis, Missouri, United States
Yale University, School of Medicine
🇺🇸New Haven, Connecticut, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States