This is a prospective, multicenter, observational study of kidney transplant subjects where blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn after transplant
This is a prospective, multicenter, observational study of kidney transplant subjects where blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn after transplant periodically and also after the treatment of acute rejection up to 8 weeks post treatment. The blood samples and all relevant clinical data will be provided to CareDx scientists for laboratory assay of dd-cfDNA levels and correlation of dd-cfDNA levels with the clinical features of the subjects. The primary objective of the study is to correlate circulating dd-cfDNA to clinical and sub-clinical acute rejection in renal allograft recipients. The secondary objective of the study is to correlate circulating dd-cfDNA to renal function, both serum creatinine and estimated glomerular filtration rate \[eGFR\]).
Study Type
OBSERVATIONAL
Enrollment
401
University of Alabama, Birmingham
Birmingham, Alabama, United States
University of California Los Angeles
Los Angeles, California, United States
Cedars-Sinai Medical Center
Clinical T cell as well as antibody mediated acute rejection
Time frame: Occurring within 12 months post transplant
Sub-clinical T cell as well as antibody mediated acute rejection
Time frame: Occurring within 12 months post transplant
Composite of clinical and sub-clinical T cell as well as antibody mediated acute rejection
Time frame: Occurring within 12 months post transplant
eGFR (estimated Glomerular Filtration Rate [mL/min]): will be derived from serum creatinine level, corrected for variables, using the CKD-RPI (Chronic Kidney Disease Epidemiology Collaboration) equation
Time frame: 24 months
Renal allograft injury from BKV nephritis, CNI toxicity, acute pyeloenephrtiis and recurrent disease confirmed by renal histology
Time frame: 24 months
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Los Angeles, California, United States
Indiana University
Indianapolis, Indiana, United States
University of Maryland
Baltimore, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
Columbia University
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Pennsylvannia
Philadelphia, Pennsylvania, United States
...and 4 more locations