Recruiting NCT07060716
Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
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
- The protocol lists: donor-derived cell-free DNA test.
- Who it may be relevant to
- Registry conditions: Kidney Transplant Rejection, Cell-free DNA. 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, Germany
- 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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Official title
GraftAssureDx Study: Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
Overview
The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit. Researchers will compare results of the GraftAssureDx to rejection detected by standard-of-care graft biopsies.
Interventions
- Diagnostic test donor-derived cell-free DNA test
A donor-derived cell-free DNA (dd-cfDNA) test used to measure the concentration of total cell-free DNA and the fractional abundance of the dd-cfDNA.
Primary outcome measures
- Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection [Time frame: Samples tested after final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 18 weeks after acquisition of the samples.]
- Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection [Time frame: Samples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.]
- Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection [Time frame: Samples tested after the assay final cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.]
- Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection [Time frame: Samples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.]
- Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection [Time frame: Samples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.]
Secondary outcome measures (2)
- ROC-AUC of dd-cfDNA vs. biopsy-confirmed rejection. [Time frame: This testing will occur from assay cutoff up to 24 weeks after acquisition of the samples.]
- Correlation between GraftAssureDx results and traditional biomarkers of kidney rejection (creatinine, estimated glomerular filtration rate, blood urea nitrogen). [Time frame: This testing will occur from assay cutoff up to 24 weeks after acquisition of the samples.]
Eligibility criteria
Inclusion criteria
- Subject is 18 years of age or older
- At least 12 calendar days have elapsed since the subject received a kidney transplant.
- Subject has provided legally effective informed consent
- Subject agrees to comply with all study procedures
Exclusion criteria
- Kidney donor is an identical twin of the subject.
- The subject has another previously transplanted organ in situ.
- Subject has received a hematopoietic stem cell transplant.
- Subject has received a bone marrow graft.
- Subject has self-reported as pregnant.
- In the opinion of the investigator, the subject's participation in the study would pose a risk to data integrity or to the subject's safety and welfare.
Sample Inclusion Criteria:
1\. A graft biopsy is obtained within ±1 week of blood draw.
- If blood draw is obtained after biopsy, blood draw should be taken at least 2 days after an uncomplicated biopsy procedure.
Sample Exclusion Criteria:
- Sample collected from someone that had an invasive graft biopsy ≤ 48 hours prior to blood draw.
- Sample collected from subject that received immunosuppressive treatment for biopsy-proven acute rejection ≤ 30 days prior to blood draw
- Sample collected from subject that received a blood transfusion ≤ 30 days prior to blood draw.
- Sample collected from a subject that provided another sample for the study within the past 7 days.
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
- Case-only
Study locations
United States · 8 centers
- University of Southern California Keck School of Medicine — Los Angeles
- Mayo Clinic in Florida — Jacksonville
- Tampa General Hospital — Tampa
- Cleveland Clinic — Cleveland
- University of Pittsburgh Medical Center — Pittsburgh
- Vanderbilt University Medical Center — Nashville
- Baylor, Scott & White Research Institute — Dallas
- Intermountain Health — Murray
Germany · 2 centers
- Institute of Immunology - Transplantation Immunology — Heidelberg
- Charite Universitatsmedizin — Berlin
Identifiers
NCT: NCT07060716 · CLN-001