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Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring

NCT07060716 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2025-11-19

No results posted yet for this study

Summary

The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit.

Researchers will compare results of the GraftAssureDx to rejection detected by standard-of-care graft biopsies.

Conditions

  • Kidney Transplant Rejection
  • Cell-free DNA

Interventions

DIAGNOSTIC_TEST

donor-derived cell-free DNA test

A donor-derived cell-free DNA (dd-cfDNA) test used to measure the concentration of total cell-free DNA and the fractional abundance of the dd-cfDNA.

Sponsors & Collaborators

  • Insight Molecular Diagnostics

    lead INDUSTRY

Principal Investigators

  • Ekkehard Schuetz, MD, PhD · Insight Molecular Diagnostics

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-08
Primary Completion
2025-11-30
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States
  • Germany

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 NCT07060716 on ClinicalTrials.gov