Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
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Phase
—
Status
Recruiting
Study type
Observational
Enrollment
125estimated
Sites
10
Countries
Germany, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-09-08 | actual | When the study began enrolling |
| Primary completion | 2025-11-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2025 | estimated | The whole study's end, after follow-up |
| First posted | 2025-07-11 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-11-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Kidney Transplant Rejection
- Cell-free DNA
Intervention
- Diagnostic test: donor-derived cell-free DNA test
Primary outcomes
what the primary-completion date above is the date OFClinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection
measured 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
measured 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
measured 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
measured 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
measured 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.
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