Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation (DART)
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ClinicalTrials.gov Identifier: NCT02424227 |
Recruitment Status : Unknown
Verified December 2018 by CareDx.
Recruitment status was: Active, not recruiting
First Posted : April 22, 2015
Last Update Posted : December 17, 2018
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Condition or disease |
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Kidney Transplant Recipients |
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 |
Actual Enrollment : | 401 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Circulating Donor-Derived Cell-free DNA in Blood for Diagnosing Acute Rejection in Kidney Transplant Recipients |
Study Start Date : | April 2015 |
Actual Primary Completion Date : | August 30, 2018 |
Estimated Study Completion Date : | January 31, 2019 |

Group/Cohort |
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Kidney Transplant Recipients
Adult living and deceased donor kidney transplant recipients will be eligible to participate in this study.
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- 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 ]
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria
- Adult recipients (Age > 18 years )
- Both genders and all racial and ethnic groups
- Kidney transplant alone
- Both living and deceased donor transplants
- Primary and re-transplants. A total of 30 re-transplant recipients across all study sites will be eligible for enrollment. CareDx will notify all centers when this subset of enrollment has been met. Thereafter, all enrolled patients should be primary transplant recipients.
- Ability to come for follow-up and undergo biopsy (Performed in accordance to SOC)
- Ability to give written informed consent prior to study enrollment
Patients can be enrolled at any time; before or after transplantation and/or at time of outpatient or inpatient visits for workup of medical problems; e.g. at the time of a renal biopsy (regardless of elapsed time since post transplant) as specified in this study protocol.
Exclusion Criteria
- Pediatric recipients (Age < 18 years)
- Pregnant women
- Patients undergoing multi-organ transplants (e.g. kidney with pancreas or liver)
- Patients receiving donor organ from an identical twin

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424227
United States, Alabama | |
University of Alabama, Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
University of California Los Angeles | |
Los Angeles, California, United States, 90024 | |
Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
United States, Indiana | |
Indiana University | |
Indianapolis, Indiana, United States, 46202 | |
United States, Maryland | |
University of Maryland | |
Baltimore, Maryland, United States, 21201 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55414 | |
United States, Missouri | |
Washington University | |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
Columbia University | |
New York, New York, United States, 10032 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
University of Pennsylvannia | |
Philadelphia, Pennsylvania, United States, 19104 | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
Baylor Research Institute | |
Fort Worth, Texas, United States, 76104 | |
Baylor Scott and White | |
Temple, Texas, United States, 76502 |
Study Director: | James Yee, MD | CareDx |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | CareDx |
ClinicalTrials.gov Identifier: | NCT02424227 |
Other Study ID Numbers: |
SN-C-00006 |
First Posted: | April 22, 2015 Key Record Dates |
Last Update Posted: | December 17, 2018 |
Last Verified: | December 2018 |