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

Completed · Not applicable

Conditions studied: Transplant;Failure,Kidney

In brief

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.

Key facts

Study ID: NCT03765203
Run by: Qure Healthcare, LLC
People needed: 175
Starts: 2018-11-05
Expected to finish: 2019-01-07
Last updated by the study team: 2020-09-16

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

A minimum of 2 years post-residency but no more than 40 years in practice
Board-certified in internal medicine
Completion of a nephrology fellowship
In a private solo or multi-group practice
Minimum threshold of 5 post-kidney transplant (KT) patients currently seen monthly
Informed, signed and voluntarily consented to be in the study

You may not qualify if…

Not board certified in internal medicine
Have practiced as a board-certified physician for less than 2 or greater than 40 years
See <5 post-transplant patients monthly
Non-English speaking
Unable to access the internet

Where it is running

QURE Healthcare — San Francisco, California, United States

Full record on ClinicalTrials.gov

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