A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Kidney Disease, Kidney Transplant, Transplant Recipient, Renal Function. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Detection of donor-derived cell-free DNA (dd-cfDNA) from whole blood [Time frame: 18 months]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 6 centers
- Scripps Health — San Diego
- University of California San Francisco — San Francisco
- Piedmont Healthcare — Atlanta
- University of Maryland Baltimore — Baltimore
- Brigham & Women's Hospital — Boston
- University of Utah — Salt Lake City
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. PMID 37951377
Identifiers
NCT: NCT07006831 · DVYUS-TDX-001