Recruiting

Observational Study

Sponsor:

Devyser Inc.

Code:

NCT07006831

Conditions

Kidney Disease

Kidney Transplant

Transplant Recipient

Renal Function

Cell-free DNA

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Kidney Disease

Kidney Transplant

Transplant Recipient

Renal Function

Cell-free DNA

Study ID

NCT07006831

Start date

Nov 14, 2025

Status verified date

Aug, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Kidney transplant recipients

Kidney transplant recipients who are 18 years of age or older

Primary outcome measure

  • Detection of donor-derived cell-free DNA (dd-cfDNA) from whole blood [ Time Frame: 18 months ]

Central Contacts and Locations

Locations

Scripps Health

Recruiting

San Diego, California, United States, 92037

Contacts

Ali Martin

858-554-4368Martin.allison@scrippshealth.org

Principal Investigator:

Christopher Marsh, MD

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Margaret Wang

415-353-1551margaret.wang2@ucsf.edu

Principal Investigator:

Amarpali Brar, MD

Piedmont Healthcare

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Janelle James, RN

404-605-4339Janelle.James1@piedmont.org

Principal Investigator:

Ana Rossi, MD

University of Maryland Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Mariela Pinedo

410-706-1375mpinedo@SOM.umaryland.edu

Principal Investigator:

Jonathan Bromberg, MD

Brigham & Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Sphoorthy Pasala

617-525-8007spasala@bwh.harvard.edu

Principal Investigator:

Jamil Azzi, MD

More Information

Sponsor

Devyser Inc.

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Devyser Inc. on 2026-08-21.