NCT04091984

The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Natera, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Kidney Transplant Rejection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Prospera	No Interventions, this is an observational study.

Timeline

• Start date: 2019-11-06
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2019-09-17
• Last updated: 2024-08-06

Locations

55 sites across 1 country: United States