Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation
- Conditions
- Kidney Transplant Recipients
- Registration Number
- NCT02424227
- Lead Sponsor
- CareDx
- Brief Summary
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
- Detailed Description
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 \[eGFR\]).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 401
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical T cell as well as antibody mediated acute rejection Occurring within 12 months post transplant Sub-clinical T cell as well as antibody mediated acute rejection Occurring within 12 months post transplant Composite of clinical and sub-clinical T cell as well as antibody mediated acute rejection Occurring within 12 months post transplant
- Secondary Outcome Measures
Name Time Method Renal allograft injury from BKV nephritis, CNI toxicity, acute pyeloenephrtiis and recurrent disease confirmed by renal histology 24 months 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 24 months
Trial Locations
- Locations (14)
University of Alabama, Birmingham
🇺🇸Birmingham, Alabama, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
Columbia University
🇺🇸New York, New York, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Baylor Scott and White
🇺🇸Temple, Texas, United States
University of Pennsylvannia
🇺🇸Philadelphia, Pennsylvania, United States
Baylor Research Institute
🇺🇸Fort Worth, Texas, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States