Status:
ACTIVE_NOT_RECRUITING
The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)
Lead Sponsor:
Natera, Inc.
Collaborating Sponsors:
University of Maryland
Conditions:
Kidney Transplant Rejection
Eligibility:
All Genders
18+ years
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 histor...
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 patient...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 6 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT04091984
Start Date
November 6 2019
End Date
October 1 2027
Last Update
August 6 2024
Active Locations (55)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Arizona Kidney Disease & Hypertension Centers
Phoenix, Arizona, United States, 85016
3
Arizona Kidney Disease & Hypertension Centers
Scottsdale, Arizona, United States, 85258
4
Arizona Kidney Disease and Hypertension Centers
Tucson, Arizona, United States, 85712