Study of Kidney Circulating Cell-free DNA in Patients With Acute Kidney Failure

Study Overview
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Brief Summary
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The amount of total circulating DNA has been shown to increase in patients with acute renal failure. Nevertheless, it is currently not currently possible to prove the renal origin of this circulating DNA. Recently, in healthy subjects, teams have shown that it is possible to identify its tissue origin of circulating DNA. CGenetix is a MedTech company which develops on an identical principle an in vitro diagnostic test capable of identifying and quantifying renal degradation during an acute trauma. The objective of this study is to evaluate the sensitivity of the proposed technology to detect circulating DNA of renal origin released into the general circulation in patients with acute organic and functional renal failure. Patients with functional or organic kidney deficiency will be included and the kidney biomarkers develop by CGenetix will be compared between these 2 groups of patients.

Detailed Description
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When the patient arrives, a first stage of checking the inclusion/non-inclusion criteria will be respected. Patients who do not meet the eligibility criteria will not be sampled (pre-screening stage). Patients meeting the eligibility criteria will be informed of the study by the investigator and a written information note will be given to them. If they do not object to their participation, an additional tube of blood for research purposes will be taken during a blood sample taken as soon as they are admitted as part of their usual treatment. They will also follow the standard care protocol according to the clinical recommendations of their attending physician. The objective of early sampling is to sensitize the test by assaying the marker as soon as possible after renal injury. In the event of a posteriori differential diagnosis (obstructive ARF or IRC), the patient will be excluded from the final analysis. Patients passing the pre-screening and screening stages positively will be included in the final analysis. 90 patients should be included and divided into 2 groups: 65 patients with non-biopsied organic acute kidney injury of which 20 patients with biopsied organic acute kidney injury (test group) 25 patients with functional acute kidney failure (control group).

Official Title
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Study of the Quantitative Evolution of Circulating Cell-free DNA of Renal Origin in Patients With Acute Renal Failure

Conditions
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Kidney Failure, Acute

Intervention / Treatment
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* Diagnostic Test: Blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years old Admitted for suspicion of acute renal injury (organic) and/or with an indication for renal biopsy (PBR) Patients hospitalized with functional acute renal failure (negative control and inclusion limited to n = 30 maximum) Exclusion Criteria: Patients < 18 years old Patients with cognitive and mental disorders making them unable to express their non-objection to participation in the study Patients with obstructive renal failure Patients with chronic renal failure Patients who expressed their refusal to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| functional kidney failure patients<br>Patients admitted to the nephrology department with suspicion of functional acute renal failures | Diagnostic Test: Blood sampling<br>* One additional blood tube will be collected for each patient included in the study using PAXgene Blood ccfDNA Tubes<br>|
| Organic kidney injury patients<br>Patients admitted to the nephrology department with suspicion of organic acute renal failure (kidney injury) | Diagnostic Test: Blood sampling<br>* One additional blood tube will be collected for each patient included in the study using PAXgene Blood ccfDNA Tubes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of circulating cell-free DNA of renal origin at baseline (at patient hospital admission in nephrology department) | Higher amount of circulating cell-free DNA of renal origin at the time of diagnosis of acute renal failure in patients with organ-type acute renal failure | Patient hospitalization time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of circulating-cell-free DNA of renal origin amounts and kidney biopsy results at baseline (at patient hospital admission in nephrology department) | Higher amount of circulating cell-free DNA of renal origin for patient with confirmed kidney lesions observed by histological analysis (kidney puncture) | Patient hospitalization time |