Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation (DART)

CareDx

Status: Unknown

Conditions: Kidney Transplant Recipients

Study type: Observational

Funder types: Industry

Identifiers

NCT02424227

SN-C-00006

Details and patient eligibility

About

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

Full 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]).

Enrollment: 401 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

401 participants in 1 patient group

Kidney Transplant Recipients

Description:

Adult living and deceased donor kidney transplant recipients will be eligible to participate in this study.