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

Completed

• Conditions: Transplant Rejection; Allograft Rejection; Complications

• Registration Number: NCT03984747
• Lead Sponsor: Natera, Inc.

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.

Study Timeline

• Study Start: 2018-09-14
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2019-06-11
• Study First Posted: 2019-06-13
• Status Verified: 2024-04
• Primary Completion: 2024-08-23
• Study Completion: 2024-08-23
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To develop an assay to detect allograft rejection status in transplant patients involving amplification of donor-derived cell-free DNA from donor recipient blood.	1-3 years	The primary outcome of the assay developed in this study would be allograft rejection high risk or low risk. This assay result will be compared to the biopsy pathology report which assesses if the transplant organ is in a state of rejection, or not. We are also measuring the donor cell free DNA, which is presumably indicating of an organ being rejected or not. Alterations in the cut off of that donor derived cell free DNA level that is allocated to high risk of rejection will be explored. Sensitivity and specificity of our assay will be calculated as needed for the purpose of validating and improving our technology in detecting donor derived cfDNA from a transplant recipient's blood. No results will be reported to patients or their treating physicians.

Trial Locations

Locations (4)

Natera Inc.; 🇺🇸 San CArlos, California, United States

Balboa United California Institute of Renal Research; 🇺🇸 San Diego, California, United States

Children's Hospital at Montefiore; 🇺🇸 Bronx, New York, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States