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NCT03765203 · ClinicalTrials.gov registry record · NA
Utility of a Novel Dd-cfDNA Test to Detect Injury in Renal Post-Transplant Patients
A NA study, sponsored by Qure Healthcare.
- Completed
- Registry status
- NA
- Development phase
- 175
- Enrollment target
NCT03765203 is a NA study that has completed, run by Qure Healthcare. The registered enrollment target is 175 participants.
The verdict
NCT03765203, a NA study, has completed, sponsored by Qure Healthcare.
- COMPLETED
- Registry status
- NA
- Development phase
- 175 participants
- Enrollment target
Study Summary
Detecting allograft injury and rejection is critical to preventing graft loss. The current standard of care (SoC) relies on serum creatinine (SC) and biopsy to monitor for and identify kidney injury earlier. SC has poor specificity and sensitivity and response to rejection is often delayed. Protocol biopsy is more accurate but involves the risk of complications. A more definitive, less invasive method for monitoring injury and early rejection is needed. We report on the clinical utility of donor-derived cell-free DNA (dd-cfDNA) in transplant recipients' blood, measured using a novel SNP-based mmPCR NGS methodology, to diagnose allograft injury/rejection. In this study, investigators will measure how use of dd-cfDNA changes clinical practice.
Interventions
- OTHER Clinical Performance and Value Vignettes
- DIAGNOSTIC_TEST Natera KidneyScan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2018-11-05 |
| Est. Completion | 2019-01-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03765203
The ClinicalTrials.gov registry entry for NCT03765203 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Qure Healthcare, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Clinical Performance and Value Vignettes is the first listed.
NCT03765203 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03765203 about?
NCT03765203 is a clinical study titled "Utility of a Novel Dd-cfDNA Test to Detect Injury in Renal Post-Transplant Patients". Detecting allograft injury and rejection is critical to preventing graft loss. The current standard of care (SoC) relies on serum creatinine (SC) and biopsy to monitor for and identify kidney injury earlier. SC has poor specificity and sensitivity and response to rejection is often delayed. Protocol...
What is the current status of trial NCT03765203?
This trial is currently completed. It is a NA study. The enrollment target is 175 participants. The study started on 2018-11-05. Estimated completion is 2019-01-07.
What interventions are being tested in trial NCT03765203?
The interventions under investigation include: Clinical Performance and Value Vignettes (OTHER), Natera KidneyScan (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03765203?
This trial is sponsored by Qure Healthcare, which has 21 total clinical trials registered on ClinicalTrials.gov.
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