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Clinical Trials in the USA / NCT04091984
Active, not recruiting Observational

The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)

NCT04091984 · tracked via the Priya Life Science USA tracker
Sponsor
Natera, Inc
Phase
Observational
Started
2019-11-06
Last updated
2024-08-06

Condition(s) studied

Kidney Transplant Rejection

Investigational drug(s) / intervention(s)

Prospera

Prospera: No Interventions, this is an observational study.

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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.

Trial sites (55)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
Arizona Kidney Disease & Hypertension Centers Phoenix Arizona
Arizona Kidney Disease & Hypertension Centers Scottsdale Arizona
Arizona Kidney Disease and Hypertension Centers Tucson Arizona
Arizona Kidney Disease & Hypertension Centers Tucson Arizona
Banner University Medical Center Tucson Arizona
University of California Davis Medical Center Davis California
University of California, Irvine Irvine California
Keck School of Medicine USC Los Angeles California
The Regents of the University of California on behalf of its Los Angeles campus Los Angeles California
Riverside Community Hospital Riverside California
California Institute of Renal Research San Diego California
University of Colorado Aurora Colorado
Hartford Hospital Hartford Connecticut
Yale University, School of Medicine New Haven Connecticut
Georgetown University Medical Center Washington D.C. District of Columbia
University of Florida Gainesville Florida
Florida Health Sciences Center Tampa Florida
Cleveland Clinic Florida (Weston) Weston Florida
Loyola University Medical Center Maywood Illinois
The University of Kansas Medical Center Research Institute Kansas City Kansas
University of Maryland Baltimore Maryland
Brigham and Women's Hospital Boston Massachusetts
Lahey Hospital and Medical Center Burlington Massachusetts
Renal Transplant Associates of New England Springfield Massachusetts
University of Michigan Ann Arbor Michigan
Harper University Hospital, Detroit Medical Center, Wayne State University Detroit Michigan
Henry Ford Health System Detroit Michigan
St. Louis University St Louis Missouri
Washington University School of Medicine in St. Louis St Louis Missouri
University of Nebraska Omaha Nebraska
University Medical Center of Southern Nevada Las Vegas Nevada
Saint Barnabas Medical Center Livingston New Jersey
Erie County Medical Center Buffalo New York
Northwell Health, Inc Manhasset New York
Columbia University Medical Center New York New York
The Research Institute at Westchester Medical Center Valhalla New York
East Carolina University Greenville North Carolina
Wake Forest University Health Sciences Winston-Salem North Carolina
The Cleveland Clinic Foundation Cleveland Ohio

+ 15 more sites — see the full list on the official registry below.

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Evaluation of the Natera Colorectal Cancer Screening Test in an Average Risk Population (FIND-CRC) Recruiting
A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy Active, not recruiting
LAMBDA 002 (Lung Registry) Study Active, not recruiting

Other trials for the same condition

A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation Recruiting
Validation of Genomic Immune-phenotyping Profiles to Predict Risk of Kidney Transplant Rejection Active, not recruiting
Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients Enrolling by invitation
Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04091984 on ClinicalTrials.gov ↗ ← All trials in the USA