Transplant RejectionSPARONCT03984747
Study for the Prediction of Active Rejection in Organs Using Donor-derived Cell-free DNA Detection
An observational study of Transplant Rejection and Allograft Rejection, run by Natera, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Transplant Rejection, Allograft Rejection, Complications
- How many people
- 110 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Sep 2018to 23 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: As in Inclusion and Exclusion criteria
Who may be able to join
- 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.
Who cannot join
- Pediatric subjects under 2 years old
- Subject received donor organ from an identical twin
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Ohio State University
Columbus, Ohio, 43221
Natera Inc.
San Carlos, California, 94070
Balboa United California Institute of Renal Research
San Diego, California, 92123
Children's Hospital at Montefiore
The Bronx, New York, 10467
About this study
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.
Read the 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.
- Conditions
- Transplant Rejection, Allograft Rejection, Complications
- Keywords
- transplant, kidney, renal, allograft, cell-free DNA, lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start14 Sep 2018
- Primary completion23 Aug 2024
- Study completion23 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984747
- Sponsor's protocol ID
- 18-038-TRP
- Acronym
- SPARO
- Status last verified
- Apr 2024
- First submitted
- 6 Nov 2018
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 30583588
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Prediction of Active Rejection in Organs Using Donor-derived Cell-free DNA Detection
- ClinicalTrials.gov ID
- NCT03984747
- Acronym / sponsor ID
- SPARO / 18-038-TRP
- Conditions
- Transplant Rejection, Allograft Rejection, Complications
- Keywords
- transplant, kidney, renal, allograft, cell-free DNA, lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Natera, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 23 Aug 2024 (actual)
- Study completion
- 23 Aug 2024 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- As in Inclusion and Exclusion criteria
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Pediatric subjects under 2 years old
- Subject received donor organ from an identical twin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Background: PubMed 30583588Sigdel 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.
- Optimizing Detection of Kidney Transplant Injury by Assessment of Donor-Derived Cell-Free DNA via Massively Multiplex PCRLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant Rejection and Allograft Rejection, run by Natera, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03984747, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.