# US 10,371,706 B2 · Biomarker of renal dysfunction

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- Number: US 10,371,706 B2
- Document ID: US10371706B2
- Status: Granted
- Kind: B2
- Application number: 14/407,603
- Filed: 2013-06-13
- Published: 2015-07-02
- Granted: 2019-08-06
- Earliest claimed: 2012-06-14
- Assignees: The Queen's University of Belfast; Belfast Health and Social Care Trust
- Applicants: The Queen's University of Belfast; Belfast Health and Social Care Trust
- Inventors: William Thomas McBride; Marilyn Armstrong
- Web page: https://patentgrep.com/patent/US10371706B2

## CPC

- G01N 33/6869: {Interleukin}
- G01N 33/6863: {Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors}
- G01N 2333/525: Tumor necrosis factor [TNF]
- G01N 2333/545: IL-1
- G01N 2333/7151: for tumor necrosis factor [TNF]; for lymphotoxin [LT]
- G01N 2333/7155: for interleukins [IL]
- G01N 2800/26: Infectious diseases, e.g. generalised sepsis
- G01N 2800/32: Cardiovascular disorders
- G01N 2800/347: Renal failures; Glomerular diseases; Tubulointerstitial diseases, e.g. nephritic syndrome, glomerulonephritis; Renovascular diseases, e.g. renal artery occlusion, nephropathy
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

The present invention relates to a method for determining predisposition of a subject to developing renal dysfunction induced by physical trauma, hypotension, sepsis and/or septic shock syndrome, wherein the method comprises the steps of:—a. determining the level of an anti-inflammatory cytokine present in a sample taken from the subject prior to physical trauma, prior to a hypotensive event, prior to sepsis, and/or prior to septic shock syndrome; b. determining if the subject is predisposed to developing renal dysfunction following physical trauma, hypotension, sepsis and/or septic shock syndrome on the basis of the level of an anti-inflammatory cytokine determined in step a).

## Claims

### Claim 1

A method of treating a subject at increased risk of renal dysfunction induced by a planned physical trauma, wherein the method comprises the step of:
a) obtaining a urine sample from a subject prior to the planned physical trauma, wherein the planned physical trauma is elective surgery;
b) detecting the anti-inflammatory cytokine present in the urine sample obtained in step a), wherein the anti-inflammatory cytokine is selected from the group consisting of IL-1ra, TNFsr1 and TNFsr2 and any combination thereof;
c) detecting the anti-inflammatory cytokine in a pre-event normal control, wherein the pre-event normal control is a normal level of anti-inflammatory cytokine presented by a control group or a predetermined normal cytokine level;
d) calculating the level of anti-inflammatory cytokine detected in step b) relative to the level of anti-inflammatory cytokine detected in step c);
e) determining that the subject has a greater than normal chance of developing renal dysfunction induced by planned physical trauma when the level of anti-inflammatory cytokine determined in step b) is lower than the level of anti-inflammatory cytokine detected in step c); and
f) applying therapeutic measures to treat or obviate renal dysfunction to the subject, wherein the therapeutic measures are selected from maintaining a supra-normal blood pressure; ensuring adequate tissue oxygen delivery; administration of steroids; renal replacement therapy; dialysis; or any combination thereof.