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Utility of a Novel Dd-cfDNA Test to Detect Injury in Renal Post-Transplant Patients

NCT03765203 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2020-09-16

No results posted yet for this 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.

Conditions

  • Transplant;Failure,Kidney

Interventions

DIAGNOSTIC_TEST

Natera KidneyScan

Online educational materials on Natera Kidneyscan (dd-cfDNA) and sample test results for simulated patients

OTHER

Clinical Performance and Value Vignettes

Online renal allograft simulated patients

Sponsors & Collaborators

  • Natera, Inc.

    collaborator INDUSTRY

  • Qure Healthcare, LLC

    lead INDUSTRY

Principal Investigators

  • John W Peabody, MD PhD · President

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-05
Primary Completion
2019-01-07
Completion
2019-01-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03765203 on ClinicalTrials.gov