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Extended Validation of Donor-derived Cell-free DNA in Kidney Transplant Recipients
Sponsor: Paris Translational Research Center for Organ Transplantation
Summary
This is a multinational, multi-center, observational cohort study. Kidney allograft rejection is poorly detected by standard-of-care biomarkers. Although dd-cfDNA has been associated with improved rejection detection when added to standard-of-care biomarkers and clinical parameters, little is known about its performance across Banff 2022 rejection phenotypes and injury patterns, in various clinical scenarios and populations, and when measured repeatedly over time.
Official title: Multinational Study to Evaluate the Performance of Donor-derived Cell-free DNA in Detecting Kidney Allograft Rejection Across Context of Use, Populations, and Injury Phenotypes
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
5000
Start Date
2024-06-15
Completion Date
2026-12-31
Last Updated
2026-09-04
Healthy Volunteers
No
Interventions
Donor-derived cell-free DNA
Cell-free DNA (cfDNA) is fragmented extracellular DNA released in the bloodstream from cells undergoing apoptosis or necrosis. In transplantation, donor-derived cfDNA (dd-cfDNA) is detected in the blood of kidney recipients and has been proposed as a noninvasive biomarker to detect rejection.
Locations (25)
Department of Medicine, Division of Nephrology, Comprehensive Transplant Center, Cedars-Sinai Medical Center, Los Angeles, CA, USA
Los Angeles, California, United States
Department of Pediatrics, Comprehensive Transplant Center, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Los Angeles, California, United States
Division of Nephrology, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
Los Angeles, California, United States
Department of Nephrology, Tampa General Hospital, Tampa, FL, USA
Tampa, Florida, United States
Division of Pediatric Nephrology, Emory University School of Medicine, Atlanta, GA, USA
Atlanta, Georgia, United States
Division of Nephrology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA
St Louis, Missouri, United States
Division of Pediatric Nephrology, Washington University School of Medicine and St. Louis Children's Hospital, St. Louis, MO, USA
St Louis, Missouri, United States
Division of Nephrology, Weill Cornell Medical College, NewYork-Presbyterian Hospital, New York, NY, USA
New York, New York, United States
Cleveland Clinic, 2050 East 96th Street, Cleveland, OH
Cleveland, Ohio, United States
Department of Medicine, Division of Nephrology, University of Texas Southwestern Medical Center, Dallas, Texas, USA
Dallas, Texas, United States
Transplant Services, Intermountain Medical Center, Murray, UT, USA
Murray, Utah, United States
Division of Nephrology, Department of Medicine, University of Utah Health, Salt Lake City, UT, USA
Salt Lake City, Utah, United States
Division of Nephrology, Virginia Commonwealth University, Richmond, VA, USA
Richmond, Virginia, United States
Department of Medicine, Division of Nephrology, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
Madison, Wisconsin, United States
Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium
Leuven, Belgium
Nephrology Division, Hospital do Rim, Fundação Osvaldo Ramos, Federal University of São Paulo, São Paulo, Brazil
São Paulo, Brazil
Department of Nephrology and Dialysis, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Cité, Paris, France
Paris, France
11- Pediatric Nephrology Department, Robert-Debré Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France
Paris, France
Hôpital Necker
Paris, France
Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris;
Paris, France
Department of Nephrology-Dialysis-Transplantation, CHU de Toulouse, Toulouse, France
Toulouse, France
Department of Nephrology and Internal Intensive Care Medicine, Charité Universitätsmedizin Berlin
Berlin, Germany
Division of Nephrology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea
Seoul, South Korea
Translational Nephrology and Kidney Transplant Research Laboratory, Vall d'Hebron Research Institute (VHIR), Barcelona, Spain
Barcelona, Spain
Service de Néphrologie, Département de Médecine, Hôpitaux Universitaires de Genève, Geneva, Switzerland
Geneva, Switzerland