The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive) (NCT04091984)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (13 items).
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
- Prospera (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (55 Sites)
Showing the first 25 of 55 sites.
- University of Alabama at Birmingham — Birmingham, Alabama
- Arizona Kidney Disease & Hypertension Centers — Phoenix, Arizona
- Arizona Kidney Disease & Hypertension Centers — Scottsdale, Arizona
- Arizona Kidney Disease and Hypertension Centers — Tucson, Arizona
- Arizona Kidney Disease & Hypertension Centers — Tucson, Arizona
- Banner University Medical Center — Tucson, Arizona
- University of California Davis Medical Center — Davis, California
- University of California, Irvine — Irvine, California
- Keck School of Medicine USC — Los Angeles, California
- The Regents of the University of California on behalf of its Los Angeles campus — Los Angeles, California
- Riverside Community Hospital — Riverside, California
- California Institute of Renal Research — San Diego, California
- University of Colorado — Aurora, Colorado
- Hartford Hospital — Hartford, Connecticut
- Yale University, School of Medicine — New Haven, Connecticut
- Georgetown University Medical Center — Washington D.C., District of Columbia
- University of Florida — Gainesville, Florida
- Florida Health Sciences Center — Tampa, Florida
- Cleveland Clinic Florida (Weston) — Weston, Florida
- Loyola University Medical Center — Maywood, Illinois
- The University of Kansas Medical Center Research Institute — Kansas City, Kansas
- University of Maryland — Baltimore, Maryland
- Brigham and Women's Hospital — Boston, Massachusetts
- Lahey Hospital and Medical Center — Burlington, Massachusetts
- Renal Transplant Associates of New England — Springfield, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Kidney Transplant Rejection
- Microbiome and Immunosuppression: The Mission Study — Minneapolis, Minnesota
- Trifecta-Kidney cfDNA-MMDx Study — Tampa, Florida
- Validation of Genomic Immune-phenotyping Profiles to Predict Risk of Kidney Transplant Rejection — Chicago, Illinois
- Treatment of Antibody-Mediated Rejection (ABMR) With CarBel — Birmingham, Alabama
- Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring — Los Angeles, California
Explore by condition: All Kidney Transplant Rejection clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.