Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation

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]).

Inclusion Criteria

1. Adult recipients (Age > 18 years )

2. Both genders and all racial and ethnic groups

3. Kidney transplant alone

4. Both living and deceased donor transplants

5. 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.

6. Ability to come for follow-up and undergo biopsy (Performed in accordance to SOC)

7. 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

1. Pediatric recipients (Age < 18 years)

2. Pregnant women

3. Patients undergoing multi-organ transplants (e.g. kidney with pancreas or liver)

4. Patients receiving donor organ from an identical twin