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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Transplant Rejection, Allograft Rejection, Kidney Transplant; Complications

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult Transplant Patients<br>Adult subjects who have undergone at least one organ transplant prior to enrollment and are willing to provide consent. | |
| Pediatric Transplant Patients<br>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<br>Pregnant subjects who have undergone at least one organ transplant prior to enrollment and are willing to provide consent. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To develop an assay to detect allograft rejection status in transplant patients involving amplification of donor-derived cell-free DNA from donor recipient blood. | 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. | 1-3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transplant, kidney, renal, allograft, cell-free DNA