The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Kidney Transplant Rejection
- Sponsor
- Natera, Inc.
- Enrollment
- 5000
- Locations
- 53
- Primary Endpoint
- Efficiency of biopsies
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Efficiency of biopsies
Time Frame: 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
Time Frame: 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 Outcomes
- Evaluate the performance of Prospera(5 years)
- Determine if and how Prospera testing impacts patient care(5 years)
- Evaluate whether Prospera can detect acute rejection earlier than serum creatinine(3 years)