Study of Kidney Circulating Cell-free DNA in Patients With Acute Kidney Failure (ADNIRA)
May 30, 2022 updated by: CGenetix
Study of the Quantitative Evolution of Circulating Cell-free DNA of Renal Origin in Patients With Acute Renal Failure
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Observational
Enrollment (Anticipated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Geoffroy Poulet, PhD
- Phone Number: +33667772394
- Email: geoffroy.poulet@cgenetix.com
Study Contact Backup
- Name: Pierre Housset, MD
- Phone Number: +33161695186
- Email: pierre.housset@chsf.fr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients admitted in nephrology service for symptome suggesting a functional or organic kidney failure.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
functional kidney failure patients
Patients admitted to the nephrology department with suspicion of functional acute renal failures
|
One additional blood tube will be collected for each patient included in the study using PAXgene Blood ccfDNA Tubes
|
|
Organic kidney injury patients
Patients admitted to the nephrology department with suspicion of organic acute renal failure (kidney injury)
|
One additional blood tube will be collected for each patient included in the study using PAXgene Blood ccfDNA Tubes
|
What is the study measuring?
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)
Time Frame: Patient hospitalization time
|
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)
Time Frame: Patient hospitalization time
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Valerie Caudwell, MD, Centre Hospitalier Sud Francilien
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bloom RD, Bromberg JS, Poggio ED, Bunnapradist S, Langone AJ, Sood P, Matas AJ, Mehta S, Mannon RB, Sharfuddin A, Fischbach B, Narayanan M, Jordan SC, Cohen D, Weir MR, Hiller D, Prasad P, Woodward RN, Grskovic M, Sninsky JJ, Yee JP, Brennan DC; Circulating Donor-Derived Cell-Free DNA in Blood for Diagnosing Active Rejection in Kidney Transplant Recipients (DART) Study Investigators. Cell-Free DNA and Active Rejection in Kidney Allografts. J Am Soc Nephrol. 2017 Jul;28(7):2221-2232. doi: 10.1681/ASN.2016091034. Epub 2017 Mar 9.
- Merkle J, Daka A, Deppe AC, Wahlers T, Paunel-Gorgulu A. High levels of cell-free DNA accurately predict late acute kidney injury in patients after cardiac surgery. PLoS One. 2019 Jun 18;14(6):e0218548. doi: 10.1371/journal.pone.0218548. eCollection 2019.
- Oellerich M, Sherwood K, Keown P, Schütz E, Beck J, Stegbauer J, Rump LC, Walson PD. Liquid biopsies: donor-derived cell-free DNA for the detection of kidney allograft injury. Nat Rev Nephrol. 2021 Sep;17(9):591-603. doi: 10.1038/s41581-021-00428-0. Epub 2021 May 24. Review.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 10, 2022
Primary Completion (Anticipated)
December 20, 2022
Study Completion (Anticipated)
January 10, 2023
Study Registration Dates
First Submitted
May 25, 2022
First Submitted That Met QC Criteria
May 30, 2022
First Posted (Actual)
June 1, 2022
Study Record Updates
Last Update Posted (Actual)
June 1, 2022
Last Update Submitted That Met QC Criteria
May 30, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDRCB 2022-A01259-34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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