Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04091984

The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Kidney Transplant Rejection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Prospera Arm:

  • 18 years of age or older
  • 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
  • A genetically different donor (not an identical twin)
  • Selected by a healthcare provider to receive Prospera dd-cfDNA test according to the regular interval testing schedule as part of their practical care
  • Able to read, understand and provide written informed consent
  • Willing and able to comply with the study visit schedule and study requirements

Exclusion criteria

Prospera Arm:

  • Pregnant
  • 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.
  • History of another organ transplant (i.e. aside from renal allograph)
  • A serious medical condition that may adversely affect ability to participate in the study (e.g, dementia, current diagnosis of cancer)
  • Previously enrolled in the ProActive Registry, with the exception of a graft failure and a new renal allograft

Inclusion criteria

Control Arm:

  • 18 years of age or older at the time of transplant
  • Had a renal allograft
  • Had a genetically different donor
  • Had a minimum of three evaluations per year during the three years since the renal allograft or until allograft failure

Exclusion criteria

Control Arm:

  • Female patients who were pregnant at any time during the 3-year historical control data collection period
  • Had a transplanted organ other than kidney
  • Received results from a dd-cfDNA test designed to assess renal allograft rejection during the historical control data collection period

Treatment and study plan

Prospera

Diagnostic Test

No Interventions, this is an observational study.

Primary outcomes

  1. 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.

  2. 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

  1. Evaluate the performance of Prospera

    Time frame: 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.

  2. Evaluate whether Prospera can detect acute rejection earlier than serum creatinine

    Time frame: 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.

  3. Determine if and how Prospera testing impacts patient care

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Natera, Inc.

Industry

Collaborators

  • University of Maryland

Registry information

Acronym: ProActive

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Sep 17, 2019
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.