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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 13, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Kidney Transplant Rejection Allograft Rejection Kidney Transplant; Complications

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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
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

Group/Cohort
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.



Primary Outcome Measures :
  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. [ 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
Each participant will provide between 1 to 4 tubes of whole blood in Streck tubes (dependent on age) and optional urine collection.


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
As in Inclusion and Exclusion criteria
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984747


Contacts
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Contact: Zach Demko, PhD 6502499090 zdemko@natera.com
Contact: Amanda Lee 6502499090 ext 1913 alee@natera.com

Locations
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United States, California
Natera Inc. Recruiting
San Carlos, California, United States, 94070
Contact: Amanda Lee    650-249-9090 ext 1913    research@natera.com   
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         
Sponsors and Collaborators
Natera, Inc.

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Responsible Party: Natera, Inc.
ClinicalTrials.gov Identifier: NCT03984747     History of Changes
Other Study ID Numbers: 18-038-TRP
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Natera, Inc.:
transplant
kidney
renal
allograft
cell-free DNA