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NCT03765203 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Qure Healthcare.

Completed
Registry status
NA
Development phase
175
Enrollment target

NCT03765203: Completed NA study, sponsored by Qure Healthcare.

NCT03765203 is a NA study that has completed, run by Qure Healthcare. The registered enrollment target is 175 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03765203, a NA study, has completed, sponsored by Qure Healthcare.

COMPLETED
Registry status
NA
Development phase
175 participants
Enrollment target

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.

Primary Outcome

Difference-in-differences regression analysis between the control and the intervention group's identification and treatment of hyperglycemia, as measured by the participants diagnostic and treatment CPV case domain scores. In each domain of a CPV (history, physical exam, workup, diagnosis and treatment), participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum to a high potential score of up to 100% in each domain.

Interventions

  • OTHER Clinical Performance and Value Vignettes
  • DIAGNOSTIC_TEST Natera KidneyScan

Trial Details

FieldValue
Enrollment Target 175 participants
Start Date 2018-11-05
Est. Completion 2019-01-07
Phase NA
Qure Healthcare

21 total trials

What the finished NCT03765203 record still lists

NCT03765203 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 2 interventions - of which Clinical Performance and Value Vignettes is the first listed.

NCT03765203 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03765203 about?

NCT03765203 is a clinical study titled "Utility of a Novel Dd-cfDNA Test to Detect Injury in Renal Post-Transplant Patients". 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...

What is the current status of trial NCT03765203?

This trial is currently completed. It is a NA study. The enrollment target is 175 participants. The study started on 2018-11-05. Estimated completion is 2019-01-07.

What interventions are being tested in trial NCT03765203?

The interventions under investigation include: Clinical Performance and Value Vignettes (OTHER), Natera KidneyScan (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT03765203?

This trial is sponsored by Qure Healthcare, which has 21 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03765203's enrollment target sits among peer trials

175 610th of 2000 higher than 1,391 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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

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Source: ClinicalTrials.gov NCT03765203, the US trial registry maintained by the National Library of Medicine. NCT03765203 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.