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RECRUITINGNCT07006831

A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population

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-d...

Lead sponsor: Devyser Inc.•6 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Devyser Inc.

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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)

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 17, 2025Terms

Trial snapshot

StatusRECRUITING

Phase—

Enrollment400

Start dateNov 2025

Last updatedDec 17, 2025

Condition

Kidney Disease Kidney Transplant Transplant Recipient Renal Function Cell-free DNA+1 more

Locations shown

Scripps Health

San Diego, California

University of California San Francisco

San Francisco, California

Piedmont Healthcare

Atlanta, Georgia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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