Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
Status unconfirmed
Conditions studied: Kidney Transplant Rejection
In brief
This is an observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making regarding the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment. Amendment 1 (A1): Is an observational study to develop and validate the clinical use of KidneyCare®.
Key facts
- Study ID
- NCT03326076
- Run by
- CareDx
- People needed
- 4000
- Starts
- 2018-01-23
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2023-06-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Loma Linda Medical Center — Loma Linda, California, United States
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- University of Southern California — Los Angeles, California, United States
- University of California, Los Angeles — Los Angeles, California, United States
- Stanford Health Care — Palo Alto, California, United States
- UC Davis Medical Center — Sacramento, California, United States
- California Pacific Medical Center — San Francisco, California, United States
- University of California San Francisco — San Francisco, California, United States
- University of Colorado Hospital — Aurora, Colorado, United States
- University of Colorado- Anschutz Medical Campus — Aurora, Colorado, United States
- Yale University — New Haven, Connecticut, United States
- Georgetown University — Washington D.C., District of Columbia, United States
- George Washington University — Washington D.C., District of Columbia, United States
- University of Miami/Jackson Memorial Hospital — Miami, Florida, United States
- AdventHealth — Orlando, Florida, United States
- Tampa General Hospital — Tampa, Florida, United States
- Cleveland Clinic - Weston — Weston, Florida, United States
- Augusta University — Augusta, Georgia, United States
- Rush University Medical Center — Chicago, Illinois, United States
- University of Illinois at Chicago — Chicago, Illinois, United States
- University of Chicago — Chicago, Illinois, United States
- Loyola University — Maywood, Illinois, United States
- Indiana University — Indianapolis, Indiana, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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