Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

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.

Details

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 overall number of surveillance biopsies when compared to routine SCr surveillance

Keywords

Kidney Transplant Rejection donor-derived cfDNA Prospera

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

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

Locations

  • University of California, Irvine accepting new patients
    Irvine California 92697 United States
  • The Regents of the University of California on behalf of its Los Angeles campus accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Natera, Inc.
ID
NCT04091984
Study Type
Observational [Patient Registry]
Last Updated