Kidney DiseaseAccept cfDNANCT07006831
A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population
An observational study of Kidney Disease and Kidney Transplant, run by Devyser Inc. at 6 sites in United States.
Trial summary
The purpose of this research is to collect blood samples and data from kidney transplant patients. The samples and data will be used for research and development of non-invasive test to detect donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients to evaluate the status of the transplanted organ. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Disease, Kidney Transplant, Transplant Recipient
- How many people
- 400 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Nov 2025to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Kidney Transplant Recipients
Who may be able to join
- Willing and able to provide written informed consent
- Is 18 years of age or older at enrollment
- Had a kidney transplant prior to enrollment
- Is having an indication (for cause) biopsy as determined by clinician
- retrospective leftover samples are available from the kidney donor(s).
Who cannot join
- Is pregnant
- Had a blood transfusion within the past 4 weeks
- Had a transplant from an identical (monozygotic) twin
- Had transplants of multiple organs from the same donor (eg, kidney and liver transplant).
- Had transplants of more than 2 organs from different donors (eg, recipient of a third kidney transplant)
- Had a transplant of hematopoietic stem cells (eg, bone marrow) or tissue (eg, heart valve)
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 5 recruiting
- Recruiting
Piedmont Healthcare
Atlanta, Georgia, 30309
Janelle James, RN, 404-605-4339, Janelle.James1@piedmont.org
Ana Rossi, MD
- Recruiting
University of Maryland Baltimore
Baltimore, Maryland, 21201
Mariela Pinedo, 410-706-1375, mpinedo@SOM.umaryland.edu
Jonathan Bromberg, MD
- Recruiting
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Sphoorthy Pasala, 617-525-8007, spasala@bwh.harvard.edu
Jamil Azzi, MD
- Completed
University of Utah
Salt Lake City, Utah, 84132
- Recruiting
Scripps Health
San Diego, California, 92037
Ali Martin, 858-554-4368, Martin.allison@scrippshealth.org
Christopher Marsh, MD
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Margaret Wang, 415-353-1551, margaret.wang2@ucsf.edu
Amarpali Brar, MD
About this study
The purpose of this research is to collect blood samples and data from kidney transplant patients. The samples and data will be used for research and development of non-invasive test to detect donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients to evaluate the status of the transplanted organ.
Read the detailed description
This is a prospective, multicenter sample collection study within a kidney transplant population.
Whole blood samples and clinical data will be obtained from each participant at the time of indication biopsy (prior to the biopsy procedure).
De-identified leftover retrospective gDNA screening samples from the paired donor(s) will also be obtained.
- Conditions
- Kidney Disease, Kidney Transplant, Transplant Recipient, Renal Function, Cell-free DNA, NGS
- Medical subject headings
- Kidney Diseases
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 |
|---|---|---|
| Kidney transplant recipients | Kidney transplant recipients who are 18 years of age or older |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of donor-derived cell-free DNA (dd-cfDNA) from whole blood
Collected samples will be used for research and development of a noninvasive in- vitro diagnostic test to detect donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start14 Nov 2025
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
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 Kidney DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Devyser Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006831
- Sponsor's protocol ID
- DVYUS-TDX-001
- Acronym
- Accept cfDNA
- Status last verified
- Aug 2026
- First submitted
- 28 May 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual participant data with other researchers. Any shared data will be de-identified data at the cohort level in aggregate.
Publications
Pettersson L, Westerling S, Talla V, Sendel A, Wennberg L, Olsson R, Hedrum A, Hauzenberger D. Development and performance of a next generation sequencing (NGS) assay for monitoring of dd-cfDNA post solid organ transplantation. Clin Chim Acta. 2024 Jan 1;552:117647. doi: 10.1016/j.cca.2023.117647. Epub 2023 Nov 10.
PubMed 37951377
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population
- ClinicalTrials.gov ID
- NCT07006831
- Acronym / sponsor ID
- Accept cfDNA / DVYUS-TDX-001
- Conditions
- Kidney Disease, Kidney Transplant, Transplant Recipient, Renal Function, Cell-free DNA, NGS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Devyser Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 5 Jun 2025 (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.
The purpose of this research is to collect blood samples and data from kidney transplant patients. The samples and data will be used for research and development of non-invasive test to detect donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients to evaluate the status of the transplanted organ.
Detailed description
This is a prospective, multicenter sample collection study within a kidney transplant population.
Whole blood samples and clinical data will be obtained from each participant at the time of indication biopsy (prior to the biopsy procedure).
De-identified leftover retrospective gDNA screening samples from the paired donor(s) will also be obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant recipients | – | –Kidney transplant recipients who are 18 years of age or older |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney Transplant Recipients
Key inclusion criteria (5 listed)
- Willing and able to provide written informed consent
- Is 18 years of age or older at enrollment
- Had a kidney transplant prior to enrollment
- Is having an indication (for cause) biopsy as determined by clinician
- retrospective leftover samples are available from the kidney donor(s).
Key exclusion criteria (6 listed)
- Is pregnant
- Had a blood transfusion within the past 4 weeks
- Had a transplant from an identical (monozygotic) twin
- Had transplants of multiple organs from the same donor (eg, kidney and liver transplant).
- Had transplants of more than 2 organs from different donors (eg, recipient of a third kidney transplant)
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
Detection of donor-derived cell-free DNA (dd-cfDNA) from whole blood
Time frame: 18 months
Collected samples will be used for research and development of a noninvasive in- vitro diagnostic test to detect donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 37951377Pettersson L, Westerling S, Talla V, Sendel A, Wennberg L, Olsson R, Hedrum A, Hauzenberger D. Development and performance of a next generation sequencing (NGS) assay for monitoring of dd-cfDNA post solid organ transplantation. Clin Chim Acta. 2024 Jan 1;552:117647. doi: 10.1016/j.cca.2023.117647. Epub 2023 Nov 10.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data with other researchers. Any shared data will be de-identified data at the cohort level in aggregate.
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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.
University of California San Francisco
San Francisco, United States
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Disease and Kidney Transplant, run by Devyser Inc. at 6 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of donor-derived cell-free DNA (dd-cfDNA) from whole blood (time frame: 18 months). 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 NCT07006831, 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 21 Aug 2026.