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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04091984
Other study ID # 18-039-TRP
Secondary ID Pro00037470
Status Recruiting
Phase
First received
Last updated
Start date November 6, 2019
Est. completion date October 1, 2027

Study information

Verified date June 2023
Source Natera, Inc.
Contact Amy Yang, BSN, RN
Phone 215.375.4817
Email proactiveprosperastudy@natera.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 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.


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 information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date October 1, 2027
Est. primary completion date October 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Prospera
No Interventions, this is an observational study.

Locations

Country Name City State
United States Lehigh Valley Health Network Allentown Pennsylvania
United States University of Michigan Ann Arbor Michigan
United States University of Colorado Aurora Colorado
United States University of Maryland Baltimore Maryland
United States Kidney Care Specialists Bethlehem Pennsylvania
United States University of Alabama at Birmingham Birmingham Alabama
United States Brigham and Women's Hospital Boston Massachusetts
United States Erie County Medical Center Buffalo New York
United States Lahey Hospital and Medical Center Burlington Massachusetts
United States The Cleveland Clinic Foundation Cleveland Ohio
United States UT Southwestern Dallas Texas
United States Geisinger Medical Center Danville Pennsylvania
United States University of California Davis Medical Center Davis California
United States Harper University Hospital, Detroit Medical Center, Wayne State University Detroit Michigan
United States Henry Ford Health System Detroit Michigan
United States St. John Hospital and Medical Center Detroit Michigan
United States University of Florida Gainesville Florida
United States East Carolina University Greenville North Carolina
United States Hartford Hospital Hartford Connecticut
United States University of California, Irvine Irvine California
United States The University of Kansas Medical Center Research Institute Kansas City Kansas
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Saint Barnabas Medical Center Livingston New Jersey
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 Northwell Health, Inc Manhasset New York
United States Loyola University Medical Center Maywood Illinois
United States West Virginia University Morgantown West Virginia
United States Vanderbilt University Nashville Tennessee
United States Yale University, School of Medicine New Haven Connecticut
United States Columbia University Medical Center New York New York
United States University of Nebraska Omaha Nebraska
United States Einstein Medical Center Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania
United States Arizona Kidney Disease & Hypertension Centers Phoenix Arizona
United States Legacy Research Portland Oregon
United States Rhode Island Hospital Providence Rhode Island
United States Virginia Commonwealth University Richmond Virginia
United States Riverside Community Hospital Riverside California
United States St. Louis University Saint Louis Missouri
United States Washington University School of Medicine in St. Louis Saint Louis Missouri
United States IHC Health Services, Inc Salt Lake City Utah
United States University of Utah Salt Lake City Utah
United States California Institute of Renal Research San Diego California
United States Arizona Kidney Disease & Hypertension Centers Scottsdale Arizona
United States University of Washington Seattle Washington
United States Renal Transplant Associates of New England Springfield Massachusetts
United States Florida Health Sciences Center Tampa Florida
United States Baylor Scott and White Research Institute Temple Texas
United States The University of Toledo Toledo Ohio
United States Arizona Kidney Disease & Hypertension Centers Tucson Arizona
United States Arizona Kidney Disease and Hypertension Centers Tucson Arizona
United States Banner University Medical Center Tucson Arizona
United States The Research Institute at Westchester Medical Center Valhalla New York
United States George Washington University Hospital Washington District of Columbia
United States Georgetown University Medical Center Washington District of Columbia
United States Cleveland Clinic Florida (Weston) Weston Florida
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Natera, Inc. University of Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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. 5 years
Secondary 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. 3 years
Secondary 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. 5 years
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