Kidney Failure, AcuteADNIRANCT05399420
Study of Kidney Circulating Cell-free DNA in Patients With Acute Kidney Failure
An observational study of Kidney Failure, Acute, run by CGenetix.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Kidney Failure, Acute
- What is being tested?
- Blood sampling
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2022to 10 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted in nephrology service for symptome suggesting a functional or organic kidney failure.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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).
- Conditions
- Kidney Failure, Acute
- Being tested
- Blood sampling
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingDiagnostic test
One additional blood tube will be collected for each patient included in the study using PAXgene Blood ccfDNA Tubes
| Study group | Role | What they receive |
|---|---|---|
| functional kidney failure patients | Patients admitted to the nephrology department with suspicion of functional acute renal failures Receives: Diagnostic Test: Blood sampling | |
| Organic kidney injury patients | Patients admitted to the nephrology department with suspicion of organic acute renal failure (kidney injury) Receives: Diagnostic Test: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Patient hospitalization time
Secondary outcomes (1)
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)
Measured: Patient hospitalization time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start10 Sep 2022 (estimated)
- Primary completion20 Dec 2022 (estimated)
- Study completion10 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CGenetix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Sud Francilien
- Responsible party
- Sponsor
- Investigators
- Valerie Caudwell, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399420
- Sponsor's protocol ID
- IDRCB 2022-A01259-34
- Acronym
- ADNIRA
- Status last verified
- May 2022
- First submitted
- 25 May 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28280140Merkle 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.
PubMed 31211810Oellerich M, Sherwood K, Keown P, Schutz 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.
PubMed 34031575
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Quantitative Evolution of Circulating Cell-free DNA of Renal Origin in Patients With Acute Renal Failure
- ClinicalTrials.gov ID
- NCT05399420
- Acronym / sponsor ID
- ADNIRA / IDRCB 2022-A01259-34
- Conditions
- Kidney Failure, Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- CGenetixIndustry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Sud Francilien
- Study start
- 10 Sep 2022 (estimated)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 10 Jan 2023 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| functional kidney failure patients | – | Diagnostic Test: Blood samplingPatients admitted to the nephrology department with suspicion of functional acute renal failures |
| Organic kidney injury patients | – | Diagnostic Test: Blood samplingPatients admitted to the nephrology department with suspicion of organic acute renal failure (kidney injury) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in nephrology service for symptome suggesting a functional or organic kidney failure.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingOne additional blood tube will be collected for each patient included in the study using PAXgene Blood ccfDNA Tubes | Diagnostic test | Organic kidney injury patients, functional kidney failure patients |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Background: PubMed 28280140Bloom 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.
- Background: PubMed 31211810Merkle 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.
- Background: PubMed 34031575Oellerich M, Sherwood K, Keown P, Schutz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Caudwell, MD principal investigator
Centre Hospitalier Sud Francilien
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Acute, run by CGenetix.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geoffroy Poulet, PhD (+33667772394, geoffroy.poulet@cgenetix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of circulating cell-free DNA of renal origin at baseline (at patient hospital admission in nephrology department) (time frame: Patient hospitalization time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05399420, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.