Study for the Prediction of Active Rejection in Organs Using Donor-derived Cell-free DNA Detection
SPARO
1 other identifier
observational
110
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2018
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 14, 2018
CompletedFirst Submitted
Initial submission to the registry
November 6, 2018
CompletedFirst Posted
Study publicly available on registry
June 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 23, 2024
CompletedMarch 18, 2025
April 1, 2024
5.9 years
November 6, 2018
March 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
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.
Eligibility Criteria
As in Inclusion and Exclusion criteria
You may qualify if:
- 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.
You may not qualify if:
- Pediatric subjects under 2 years old
- Subject received donor organ from an identical twin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Natera, Inc.lead
Study Sites (4)
Natera Inc.
San Carlos, California, 94070, United States
Balboa United California Institute of Renal Research
San Diego, California, 92123, United States
Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
The Ohio State University
Columbus, Ohio, 43221, United States
Related Publications (1)
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.
PMID: 30583588BACKGROUND
Related Links
Biospecimen
Each participant will provide between 1 to 4 tubes of whole blood (dependent on age) and optional urine collection.
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2018
First Posted
June 13, 2019
Study Start
September 14, 2018
Primary Completion
August 23, 2024
Study Completion
August 23, 2024
Last Updated
March 18, 2025
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share
12.4.1 All laboratory specimens, evaluation forms, reports, and other records will be handled in a manner designed to maintain research participant confidentiality. All records will be kept in a secure storage area with limited access. Clinical information will not be released without the written permission of the research participant's guardian except as necessary for monitoring and auditing by the Sponsor, its designee, regulatory bodies, or the IRB, or the DSMB. 12.4.2 The Principal Investigator or Sub-Investigator and all employees and coworkers involved with this study may not disclose or use for any purpose other than performance of the study, any data, record, or other unpublished, confidential information disclosed to those individuals for the purpose of the study. Prior written agreement from the Sponsor or its designee must be obtained for the disclosure of any said confidential information to other parties