Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
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Phase
—
Status
Unknown status
Study type
Observational
Enrollment
4,000estimated
Sites
72
Country
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 | 2018-01-23 | actual | When the study began enrolling |
| Primary completion | 2025-06-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2017-10-30 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2023-06-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Kidney Transplant Rejection
Interventions
- Diagnostic test: Donor-derived cell-free DNA (AlloSure®)
- Other: Standard care
- Diagnostic test: Peripheral blood gene expression profiling (AlloMap Kidney)
- Diagnostic test: Analytic platform (IBox)
Primary outcomes
what the primary-completion date above is the date OFInterstitial fibrosis/tubular atrophy (IF/TA) quantified by Banff Working Group biopsy grade(s) at 12 months post-transplant in AlloSure® and renal allograft biopsy managed patients
measured Feb-2020
Total number of biopsies planned and performed post-transplant, including both surveillance and clinically indicated biopsies
measured Feb-2020
Publications
- PMID 28280140 — cited as background
- PMID 27727019 — cited as background
- PMID 42302101 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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