A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population
NCT ID: NCT07006831
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2025-11-14
2027-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Kidney transplant recipients
Kidney transplant recipients who are 18 years of age or older
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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Devyser Inc.
INDUSTRY
Responsible Party
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Locations
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Scripps Health
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Piedmont Healthcare
Atlanta, Georgia, United States
University of Maryland Baltimore
Baltimore, Maryland, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Facility Contacts
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References
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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.
Other Identifiers
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DVYUS-TDX-001
Identifier Type: -
Identifier Source: org_study_id