The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)

Active, not recruiting

• Conditions: Kidney Transplant Rejection

• 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

Study Timeline

• Study First Submitted: 2019-09-06
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-17
• Study Start: 2019-11-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-06
• Primary Completion: 2026-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, 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

University of California Davis Medical Center; 🇺🇸 Davis, California, United States

University of California, Irvine; 🇺🇸 Irvine, 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

Riverside Community Hospital; 🇺🇸 Riverside, California, United States

California Institute of Renal Research; 🇺🇸 San Diego, California, United States

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