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NCT07060716 · ClinicalTrials.gov registry record
Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
A clinical trial of Kidney Transplant Rejection and Cell-free DNA, sponsored by Insight Molecular Diagnostics.
- Recruiting
- Registry status
- 125
- Enrollment target
- 10
- Study locations
NCT07060716: Recruiting study of Kidney Transplant Rejection and Cell-free DNA, sponsored by Insight Molecular Diagnostics.
NCT07060716 is a study of Kidney Transplant Rejection and Cell-free DNA that is actively recruiting participants, run by Insight Molecular Diagnostics. The registered enrollment target is 125 participants, below the 790-participant average among 8 other Kidney Transplant Rejection trials with a reported enrollment target (84% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07060716, a study of Kidney Transplant Rejection and Cell-free DNA, is actively recruiting participants, sponsored by Insight Molecular Diagnostics.
- RECRUITING
- Registry status
- 125 participants
- Enrollment target
- 10
- Study locations
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.
Primary Outcome
Relative percentage of dd-cfDNA levels of 0.5% and absolute values of 50cp/mL are considered to be the diagnostic cutoff for rejection, which will be refined during the first study phase.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST donor-derived cell-free DNA test
Study Locations (10)
Florida
- Mayo Clinic in Florida - Jacksonville
- Tampa General Hospital - Tampa
California
- University of Southern California Keck School of Medicine - Los Angeles
Ohio
- Cleveland Clinic - Cleveland
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Tennessee
- Vanderbilt University Medical Center - Nashville
Texas
- Baylor, Scott & White Research Institute - Dallas
Utah
- Intermountain Health - Murray
Baden-Wurttemberg
- Institute of Immunology - Transplantation Immunology - Heidelberg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2025-09-08 |
| Est. Completion | 2025-12 |
What NCT07060716 shows while recruiting
NCT07060716 is an observational study that tracks outcomes without assigning an intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 790-participant average among 8 other Kidney Transplant Rejection trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Kidney Transplant Rejection appearing as the primary indexed condition, and to 1 intervention - of which donor-derived cell-free DNA test is the first listed.
NCT07060716 lists 10 locations in 9 states (Florida, California, Ohio).
Frequently Asked Questions
What is clinical trial NCT07060716 about?
NCT07060716 is a clinical study titled "Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring". 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 detecte...
What is the current status of trial NCT07060716?
This trial is currently recruiting. The enrollment target is 125 participants. The study started on 2025-09-08. Estimated completion is 2025-12.
What conditions does trial NCT07060716 study?
This clinical trial studies the following conditions: Kidney Transplant Rejection, Cell-free DNA.
What interventions are being tested in trial NCT07060716?
The interventions under investigation include: donor-derived cell-free DNA test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07060716?
This trial is sponsored by Insight Molecular Diagnostics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07060716 being conducted?
This trial has 10 study locations across California, Florida, Ohio, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kidney Transplant Rejection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07060716's enrollment target sits among peer trials
125 6th of 8 higher than 3 of 8 other Kidney Transplant Rejection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Transplant Rejection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Trifecta-Kidney cfDNA-MMDx Study
RECRUITING
-
Evaluating Urinary CXCL10 for Enhanced Detection of Acute Rejection in Kidney Transplant Patients With Low DD-CFDNA
RECRUITING
-
Microbiome and Immunosuppression: The Mission Study
ACTIVE NOT RECRUITING
-
The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)
ACTIVE NOT RECRUITING
-
Validation of Genomic Immune-phenotyping Profiles to Predict Risk of Kidney Transplant Rejection
ACTIVE NOT RECRUITING
-
Longitudinal Changes in Donor-Derived Cell-Free DNA With Tocilizumab Treatment for Chronic Antibody-Mediated Rejection
ACTIVE NOT RECRUITING
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