Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInsight Molecular Diagnostics
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Individuals who have received a kidney transplant at centers in the United States and Germany will be invited to participate.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
donor-derived cell-free DNA test
Diagnostic testA 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.2
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.3
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.4
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.Secondary outcomes
1
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.2
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov