Clinical trial NCT03984747: Study for the Prediction of Active Rejection in Organs Using Donor-derived Cell-free DNA Detection
Official title: Study for the Prediction of Active Rejection in Organs Using Donor-derived Cell-free DNA Detection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transplant Rejection
Allograft Rejection
Complications
Keywords: transplant
kidney
renal
allograft
cell-free DNA
lung
Lead sponsor: Natera, Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-13
Enrollment: 110
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As in Inclusion and Exclusion criteria

Brief summary: This is a multi-center prospective study designed to collect blood samples from transplant patients in order to improve Natera's method for determining allograft rejection status using the donor-derived cell-free DNA analysis, called Prospera.

Detailed description: This is a multi-center prospective study designed to collect blood samples from transplant patients in order to improve Natera's method for determining allograft rejection status using the donor-derived cell-free DNA analysis, called Prospera.

Subjects who have had an organ transplant, who present at the clinic for a standard of care visit or consent for an extra research blood samples to be taken by mobile phlebotomy, meet the study's eligibility criteria and are willing to participate in this research, will be consented and enrolled in this study.

Subjects will provide at least one blood sample at study enrollment and up to three optional follow-up blood samples at future visits. Relevant medical data will also be collected for each patient enrolled.

Urine samples may also be collected at the above described time-points.

Up to 500 subjects over the age of 2 worldwide who meet the study eligibility criteria are expected to be enrolled in this study. The study includes adult, pregnant, and pediatric subjects.

Eligibility criteria: Inclusion Criteria:

* Subject must be 2 years old or older at the time of enrollment
* Subject or Legally Authorized Representative is willing and able to sign the informed consent form (and assent form, if applicable), prior to participation in any study-related procedures.
* Subject has received at least one organ transplant prior to enrollment.

Exclusion Criteria:

* Pediatric subjects under 2 years old
* Subject received donor organ from an identical twin

Primary outcomes:
measure: To develop an assay to detect allograft rejection status in transplant patients involving amplification of donor-derived cell-free DNA from donor recipient blood.
timeFrame: 1-3 years
Secondary outcomes:
Other outcomes:
Locations:
city: San CArlos
country: United States
facility: Natera Inc.
state: California
city: San Diego
country: United States
facility: Balboa United California Institute of Renal Research
state: California
city: Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References:
citation: Sigdel TK, Archila FA, Constantin T, Prins SA, Liberto J, Damm I, Towfighi P, Navarro S, Kirkizlar E, Demko ZP, Ryan A, Sigurjonsson S, Sarwal RD, Hseish SC, Chan-On C, Zimmermann B, Billings PR, Moshkevich S, Sarwal MM. Optimizing Detection of Kidney Transplant Injury by Assessment of Donor-Derived Cell-Free DNA via Massively Multiplex PCR. J Clin Med. 2018 Dec 23;8(1):19. doi: 10.3390/jcm8010019.