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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Subject is 18 years of age or older
2. At least 12 calendar days have elapsed since the subject received a kidney transplant.
3. Subject has provided legally effective informed consent
4. Subject agrees to comply with all study procedures
Exclusion Criteria:
1. Kidney donor is an identical twin of the subject.
2. The subject has another previously transplanted organ in situ.
3. Subject has received a hematopoietic stem cell transplant.
4. Subject has received a bone marrow graft.
5. Subject has self-reported as pregnant.
6. 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:
1. Sample collected from someone that had an invasive graft biopsy ≤ 48 hours prior to blood draw.
2. Sample collected from subject that received immunosuppressive treatment for biopsy-proven acute rejection ≤ 30 days prior to blood draw
3. Sample collected from subject that received a blood transfusion ≤ 30 days prior to blood draw.
4. Sample collected from a subject that provided another sample for the study within the past 7 days.
Primary outcome measure(s)
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection — 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. Relative percentage of dd-cfDNA levels of 0.5% and absolute values of 50cp/mL are considered to be the diagnostic cutoff for rejection, which will be refined during the first study phase.
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection — 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 sensitivity of the dd-cfDNA test shall be better or equal to published values (≥56%). Current literature shows an average sensitivity of 69% with a SD of 13%. Therefore, 56% represents the lower boundary (average - 1SD) of the distribution of published values.
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection — 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 Specificity of the dd-cfDNA test shall be better or equal to published values (≥75%). Current literature shows an average specificity of 81% with a SD of 6%. Therefore, 75% represents the lower boundary (average - 1SD) of the distribution of published values.
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection — 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. Predictive values are mathematically derived from sensitivity and specificity using the Bayes' theorem. Therefore, success criteria are defined as the lower boundary of the current literature at any given a priori probability. E.g., for an a priori probability of 20%, the lower boundary for NPV is 85%.
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection — 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. Predictive values are mathematically derived from sensitivity and specificity using the Bayes' theorem. Therefore, success criteria are defined as the lower boundary of the current literature at any given a priori probability. E.g., for an a priori probability of 20%, the lower boundary for Positive Predictive Value (PPV) is 49%.
Trial sites (10)
Facility
City
Region
Status
University of Southern California Keck School of Medicine
Los Angeles
California
Active Not Recruiting
Mayo Clinic in Florida
Jacksonville
Florida
Recruiting
Tampa General Hospital
Tampa
Florida
Recruiting
Cleveland Clinic
Cleveland
Ohio
Recruiting
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
Active Not Recruiting
Vanderbilt University Medical Center
Nashville
Tennessee
Recruiting
Baylor, Scott & White Research Institute
Dallas
Texas
Recruiting
Intermountain Health
Murray
Utah
Recruiting
Institute of Immunology - Transplantation Immunology
Heidelberg
Baden-Wurttemberg
Active Not Recruiting
Charite Universitatsmedizin
Berlin
Germany
Active Not Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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