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ACTIVE NOT RECRUITING
NCT07805343

Extended Validation of Donor-derived Cell-free DNA in Kidney Transplant Recipients

Sponsor: Paris Translational Research Center for Organ Transplantation

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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