Study for the Prediction of Active Rejection in Organs Using Donor-derived Cell-free DNA Detection (SPARO)
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|ClinicalTrials.gov Identifier: NCT03984747|
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 24, 2019
|Condition or disease|
|Kidney Transplant Rejection Allograft Rejection Kidney Transplant; Complications|
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 Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Study for the Prediction of Active Rejection in Organs Using Donor-derived Cell-free DNA Detection|
|Actual Study Start Date :||September 14, 2018|
|Estimated Primary Completion Date :||October 30, 2028|
|Estimated Study Completion Date :||October 30, 2028|
Adult Transplant Patients
Adult subjects who have undergone at least one organ transplant prior to enrollment and are willing to provide consent.
Pediatric Transplant Patients
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
Pregnant subjects who have undergone at least one organ transplant prior to enrollment and are willing to provide consent.
- To develop an assay to detect allograft rejection status in transplant patients involving amplification of donor-derived cell-free DNA from donor recipient blood. [ Time Frame: 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984747
|Contact: Zach Demko, PhDfirstname.lastname@example.org|
|Contact: Amanda Lee||6502499090 ext email@example.com|
|United States, California|
|San Carlos, California, United States, 94070|
|Contact: Amanda Lee 650-249-9090 ext 1913 firstname.lastname@example.org|
|Principal Investigator: Zachary Demko, PhD|
|Balboa United California Institute of Renal Research||Recruiting|
|San Diego, California, United States, 92123|
|Contact: Eva Gripp 858-637-4600|
|Contact: Karina Maldonado|
|Sub-Investigator: Arman Faravardeh, MD|