Prospective blood collection to detect donor-derived cell-free DNA after kidney transplant
Official title: A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population
Run by Devyser Inc. · NCT07006831 · Data updated 2026-11-12
This project will collect blood from adults who had a kidney transplant to try a blood test that detects donor-derived cell-free DNA to check the transplanted organ.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Devyser Inc. Industry-sponsored |
| Locations | 7 sites (San Diego, California and 6 other locations) |
| Status | Recruiting |
| Started | November 14, 2025 |
| Main results expected | December 2027 |
| Study ends | March 2028 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07006831 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) who previously received a kidney transplant, are undergoing a clinician‑directed (for‑cause) kidney biopsy, and have retrospective donor DNA samples available are the intended participants.
✕Probably not a fit
People who are pregnant, had a blood transfusion within 4 weeks, received a transplant from an identical twin, had multiple‑organ transplants or hematopoietic stem cell/tissue transplants, or who are not undergoing an indication biopsy are excluded and therefore unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter effort to collect whole blood and clinical data from kidney transplant recipients at the time they undergo a clinician‑directed (for‑cause) biopsy. Samples are collected prior to the biopsy procedure and paired with de‑identified leftover genomic DNA from the donor when available. The collected material will be used to develop and refine non‑invasive tests that measure donor‑derived cell‑free DNA (dd‑cfDNA) as a marker of graft status. Data and samples will support research and development of dd‑cfDNA assays and associated clinical interpretation.
Why it matters
Potential benefit: If successful, this could lead to a non‑invasive blood test that helps detect injury or rejection of a transplanted kidney earlier or with less need for biopsy.
How similar studies have gone: Other studies and commercial dd‑cfDNA tests have shown promise for detecting transplant injury and rejection, though methods and performance vary and additional validation remains necessary.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Is 18 years of age or older at enrollment 3. Had a kidney transplant prior to enrollment 4. Is having an indication (for cause) biopsy as determined by clinician 5. retrospective leftover samples are available from the kidney donor(s). Exclusion Criteria: 1. Is pregnant 2. Had a blood transfusion within the past 4 weeks 3. Had a transplant from an identical (monozygotic) twin 4. Had transplants of multiple organs from the same donor (eg, kidney and liver transplant). 5. Had transplants of more than 2 organs from different donors (eg, recipient of a third kidney transplant) 6. Had a transplant of hematopoietic stem cells (eg, bone marrow) or tissue (eg, heart valve)
Where it's running
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Scripps Health
San Diego, California, United States Recruiting -
University of California San Francisco
San Francisco, California, United States Recruiting -
Piedmont Healthcare
Atlanta, Georgia, United States Recruiting -
University of Maryland Baltimore
Baltimore, Maryland, United States Recruiting -
Brigham & Women's Hospital
Boston, Massachusetts, United States Recruiting -
Methodist Hospital
San Antonio, Texas, United States Recruiting
Show 1 more location
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University of Utah
Salt Lake City, Utah, United States Completed
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.