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NCT04091984 · ClinicalTrials.gov registry record
The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)
A clinical trial of Kidney Transplant Rejection, sponsored by Natera.
- Active
- Registry status
- 5,000
- Enrollment target
- 20
- Study locations
NCT04091984: Active study of Kidney Transplant Rejection, sponsored by Natera.
NCT04091984 is a study of Kidney Transplant Rejection that is active but no longer recruiting, run by Natera. The registered enrollment target is 5,000 participants, above the 180-participant average among 8 other Kidney Transplant Rejection trials with a reported enrollment target (2678% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04091984, a study of Kidney Transplant Rejection, is active but no longer recruiting, sponsored by Natera.
- ACTIVE NOT RECRUITING
- Registry status
- 5,000 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Prospera
Study Locations (20)
California
- University of California Davis Medical Center - Davis
- University of California, Irvine - Irvine
- Keck School of Medicine USC - Los Angeles
- The Regents of the University of California on behalf of its Los Angeles campus - Los Angeles
- Riverside Community Hospital - Riverside
- California Institute of Renal Research - San Diego
Arizona
- Arizona Kidney Disease & Hypertension Centers - Phoenix
- Arizona Kidney Disease & Hypertension Centers - Scottsdale
- Arizona Kidney Disease and Hypertension Centers - Tucson
- Arizona Kidney Disease & Hypertension Centers - Tucson
- Banner University Medical Center - Tucson
Florida
- University of Florida - Gainesville
- Florida Health Sciences Center - Tampa
- Cleveland Clinic Florida (Weston) - Weston
Connecticut
- Hartford Hospital - Hartford
- Yale University, School of Medicine - New Haven
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- University of Colorado - Aurora
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Illinois
- Loyola University Medical Center - Maywood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,000 participants |
| Start Date | 2019-11-06 |
| Est. Completion | 2027-10-01 |
What the registry record for NCT04091984 still lists
NCT04091984 is an observational study that tracks outcomes without assigning an intervention. Its 5,000 participants enrollment target places it among the larger protocols in the corpus, above the 180-participant average among 8 other Kidney Transplant Rejection trials with a reported enrollment target (2678% higher).
The record links to 1 condition, with Kidney Transplant Rejection appearing as the primary indexed condition, and to 1 intervention - of which Prospera is the first listed.
NCT04091984 names 20 study sites across 8 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT04091984 about?
NCT04091984 is a clinical study titled "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 ...
What is the current status of trial NCT04091984?
This trial is currently active not recruiting. The enrollment target is 5,000 participants. The study started on 2019-11-06. Estimated completion is 2027-10-01.
What conditions does trial NCT04091984 study?
This clinical trial studies the following conditions: Kidney Transplant Rejection.
What interventions are being tested in trial NCT04091984?
The interventions under investigation include: Prospera (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04091984?
This trial is sponsored by Natera, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04091984 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kidney Transplant Rejection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04091984's enrollment target sits among peer trials
5,000 1st of 8 higher than 8 of 8 other Kidney Transplant Rejection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Transplant Rejection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Trifecta-Kidney cfDNA-MMDx Study
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Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
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Microbiome and Immunosuppression: The Mission Study
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Validation of Genomic Immune-phenotyping Profiles to Predict Risk of Kidney Transplant Rejection
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Longitudinal Changes in Donor-Derived Cell-Free DNA With Tocilizumab Treatment for Chronic Antibody-Mediated Rejection
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