Study for the Prediction of Active Rejection in Organs Using Donor-derived Cell-free DNA Detection (SPARO)

Natera

Status: Completed

Conditions: Complications; Allograft Rejection; Transplant Rejection

Study type: Observational

Funder types: Industry

Identifiers

NCT03984747

18-038-TRP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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

Trial design

110 participants in 3 patient groups

Adult Transplant Patients

Description:

Adult subjects who have undergone at least one organ transplant prior to enrollment and are willing to provide consent.

Pediatric Transplant Patients

Description:

Pediatric subjects between ages 2-17 who have undergone at least one organ transplant prior to enrollment and are willing to provide assent/LAR is willing to provide consent.

Pregnant Transplant Patients

Description:

Pregnant subjects who have undergone at least one organ transplant prior to enrollment and are willing to provide consent.