4,000
Participants
Start Date
January 23, 2018
Primary Completion Date
June 30, 2025
Study Completion Date
December 31, 2025
Donor-derived cell-free DNA (AlloSure®)
Patients will receive donor-derived cell-free DNA testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
Standard care
Current standard methods for monitoring of renal allograft recipients for rejection (e.g. donor-specific antibodies, serum creatinine, proteinuria, renal allograft biopsy)
Peripheral blood gene expression profiling (AlloMap Kidney)
Patients will receive peripheral blood gene expression profiling testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
Analytic platform (IBox)
Patients will receive IBox testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
Montefiore Medical Center, The Bronx
SUNY Downstate Medical Center, Brooklyn
Erie County Medical Center, Buffalo
Allegheny General Hospital, Pittsburgh
University of Pittsburgh Medical Center, Pittsburgh
Hospital of the University of Pennsylvania, Philadelphia
Georgetown University, Washington D.C.
George Washington University, Washington D.C.
University of Maryland, Baltimore
Johns Hopkins University, Baltimore
Inova Fairfax Hospital, Falls Church
Duke University, Durham
Virginia Commonwealth University, Richmond
Wake Forest Baptist Medical Center- Department of General Surgery, Winston-Salem
East Carolina University/Vidant Medical Center, Greenville
Metrolina Nephrology Associates, Charlotte
Medical University of South Carolina, Charleston
Augusta University, Augusta
AdventHealth, Orlando
University of Miami/Jackson Memorial Hospital, Miami
Cleveland Clinic - Weston, Weston
Tampa General Hospital, Tampa
University of Alabama at Birmingham, Birmingham
Vanderbilt University Medical Center, Nashville
Methodist Healthcare Foundation, Memphis
University of Mississippi Medical Center, Jackson
University of Kentucky Chandler Hospital, Lexington
Ohio State University Medical Center, Columbus
Cleveland Clinic Foundation, Cleveland
Indiana University, Indianapolis
University of Minnesota Medical Center, Minneapolis
Loyola University, Maywood
Rush University Medical Center, Chicago
University of Illinois at Chicago, Chicago
University of Chicago, Chicago
Washington University (Barnes Jewish Hospital), St Louis
Washington University, St Louis
The University of Missouri, Columbia
University of Kansas Medical Center, Kansas City
University of Nebraska Medical Center, Omaha
Tulane University Medical Center, New Orleans
Ochsner Foundation Hospital, New Orleans
Willis-Knighton Physician Network/ John C. McDonald Regional Transplant Center, Shreveport
The Oklahoma Transplant Center at OU Medical Center, Oklahoma City
Integris Baptist Medical Center, Oklahoma City
UT Southwestern, Dallas
Baylor All Saints Medical Center, Fort Worth
Texas Research Institute, Fort Worth
Baylor Scott & White Medical Center, Temple
Houston Methodist Hospital, Houston
UT Health San Antonio, San Antonio
University of Colorado Hospital, Aurora
University of Colorado- Anschutz Medical Campus, Aurora
Intermountain Medical Center, Murray
University of Utah, Salt Lake City
Cedars-Sinai Medical Center, Los Angeles
University of Southern California, Los Angeles
University of California, Los Angeles, Los Angeles
Loma Linda Medical Center, Loma Linda
California Pacific Medical Center, San Francisco
University of California San Francisco, San Francisco
Stanford Health Care, Palo Alto
UC Davis Medical Center, Sacramento
University of Washington Medical Center, Seattle
Sacred Heart Medical Center, Spokane
Yale University, New Haven
Brigham and Women's Hospital, Boston
Massachusetts General Hospital, Boston
Beth Israel Deaconess Medical Center, Boston
Saint Barnabus Medical Center, Livingston
Geisinger Clinic, Danville
Rhode Island Hospital, Providence
Lead Sponsor
CareDx
INDUSTRY