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

NCT05399420 | Unknown

• 1 other identifier: IDRCB 2022-A01259-34
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Kidney Failure, Acute

Outcome Measures

Primary Outcomes (1)

• 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 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)

  Patient hospitalization time

Study Arms (2)

functional kidney failure patients

Patients admitted to the nephrology department with suspicion of functional acute renal failures

Diagnostic Test: Blood sampling

Organic kidney injury patients

Patients admitted to the nephrology department with suspicion of organic acute renal failure (kidney injury)

Diagnostic Test: Blood sampling

Interventions

Blood sampling DIAGNOSTIC_TEST

One additional blood tube will be collected for each patient included in the study using PAXgene Blood ccfDNA Tubes

Organic kidney injury patients; functional kidney failure patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted in nephrology service for symptome suggesting a functional or organic kidney failure.

You may qualify if:

• Age \> 18 years old
• Admitted for suspicion of acute renal injury (organic) and/or with an indication for renal biopsy (PBR)

You may not qualify if:

• 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

Sponsors & Collaborators

• CGenetix: lead
• Centre Hospitalier Sud Francilien: collaborator

Related Publications (3)

• 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.

  PMID: 28280140 BACKGROUND

• 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.

  PMID: 31211810 BACKGROUND

• Oellerich 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.

  PMID: 34031575 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma sample (1 additional blood tube) from patients with functional kidney deficiency or organic kidney injury

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Valerie Caudwell, MD

  Centre Hospitalier Sud Francilien

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geoffroy Poulet, PhD

CONTACT

+33667772394; geoffroy.poulet@cgenetix.com

Pierre Housset, MD

CONTACT

+33161695186; pierre.housset@chsf.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 1, 2022
• Study Start: September 10, 2022
• Primary Completion: December 20, 2022
• Study Completion: January 10, 2023
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share