Utility of a Novel Dd-cfDNA Test to Detect Injury in Renal Post-Transplant Patients
Public ClinicalTrials.gov record NCT03765203. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective, Randomized Controlled Trial Using CPV Vignettes to Assess the Clinical Utility of Natera Dd-cfDNA Test to Detect Allograft in Post-Transplant Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03765203
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 175 participants
Conditions and interventions
Conditions
Interventions
- Natera KidneyScan Diagnostic Test
- Clinical Performance and Value Vignettes Other
Diagnostic Test · Other
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 4, 2018
- Primary completion
- Jan 6, 2019
- Completion
- Jan 6, 2019
- Last update posted
- Sep 15, 2020
2018 – 2019
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| QURE Healthcare | San Francisco | California | 94109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03765203, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 15, 2020 · Synced Sep 15, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03765203 live on ClinicalTrials.gov.