An observational study in Kidney Transplant Rejection and Cell-free DNA, sponsored by Insight Molecular Diagnostics. Recruiting at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Insight Molecular Diagnostics · Observational
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.
Insight Molecular Diagnostics is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Individuals who have received a kidney transplant at centers in the United States and Germany will be invited to participate.
Exclusion Criteria:
Sample Inclusion Criteria:
1. A graft biopsy is obtained within ±1 week of blood draw.
Sample Exclusion Criteria:
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.
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection
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.
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
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.
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
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.
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
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%.
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
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%.
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.
ROC-AUC of dd-cfDNA vs. biopsy-confirmed rejection.
The second endpoint is for investigational use only and therefore has no predefined success criteria.
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).
The second endpoint is for investigational use only and therefore has no predefined success criteria.
Time frame: This testing will occur from assay cutoff up to 24 weeks after acquisition of the samples.
Plan to share: Undecided — only IPD used in the results publication
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