Donor Derived Cell-free DNA and Rejection of Kidney Allografts

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-21

Study Completion Date

2022-08-09

Brief Summary

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To assess the association of dd-cfDNA with the presence, activity and severity of allograft rejection, and determine whether dd-cfDNA adds value to standard of care monitoring parameters in detecting kidney allograft rejection.

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Detailed Description

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Conditions

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Kidney Rejection Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Derivation cohort

Donor-derived cell-free DNA

Intervention Type DIAGNOSTIC_TEST

Cell-free DNA (cfDNA) is fragmented extracellular DNA released in the bloodstream from cells undergoing apoptosis or necrosis. In transplantation, donor-derived cfDNA (dd-cfDNA) is detected in the blood of kidney recipients and has been proposed as a noninvasive biomarker to detect rejection.

One additional blood sample will be collected and dd-cfDNA levels will be centrally analyzed.

Validation cohort

Donor-derived cell-free DNA

Intervention Type DIAGNOSTIC_TEST

Cell-free DNA (cfDNA) is fragmented extracellular DNA released in the bloodstream from cells undergoing apoptosis or necrosis. In transplantation, donor-derived cfDNA (dd-cfDNA) is detected in the blood of kidney recipients and has been proposed as a noninvasive biomarker to detect rejection.

One additional blood sample will be collected and dd-cfDNA levels will be centrally analyzed.

Interventions

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