# US 2013/0157252 A1 · Diagnostic marker for kidney diseases and use thereof

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- Number: US 2013/0157252 A1
- Document ID: US20130157252A1
- Status: Published application
- Kind: A1
- Application number: 13/660,440
- Filed: 2012-10-25
- Published: 2013-06-20
- Earliest claimed: 2010-04-27
- Assignees: Human Metabolome Technologies, Inc.; Sysmex Corporation
- Inventors: Hajime SATO; Yoshiaki OHASHI; Kazunori SASAKI; Kouzou SUTO; Yasuhiro OTOMO
- Web page: https://patentgrep.com/patent/US20130157252A1

## CPC

- G01N 27/62: by investigating the ionisation of gases, e.g. aerosols; by investigating electric discharges, e.g. emission of cathode
- G01N 33/6806: {Determination of free amino acids}
- G01N 33/6893: {related to diseases not provided for elsewhere}
- G01N 2800/347: Renal failures; Glomerular diseases; Tubulointerstitial diseases, e.g. nephritic syndrome, glomerulonephritis; Renovascular diseases, e.g. renal artery occlusion, nephropathy
- 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 novel diagnostic markers for kidney disease and the use thereof.

## Claims

### Claim 1

A diagnostic marker for kidney disease which is at least one selected from:
glycolic acid;
N5-[(dimethylamino)iminomethyl]-ornithine;
5-oxo-2-tetrahydrofuran carboxylic acid;
a combination consisting of trimethylglycine and any one substance selected from glycolic acid, N5-[(dimethylamino)iminomethyl]-ornithine, guanidinoacetic acid, 4-guanidinobutyric acid, N6-acetyllysine, N1-acetylhistidine and histidine;
a combination consisting of glycolic acid and any one substance selected from N5-[dimethylamino)iminomethyl]-ornithine, cytidine, valine, kynurenine, 2-oxoglutaric acid, glycocyamidine and choline;
a combination consisting of cystine and any one substance selected from N1-acetylhistidine, histidine, glycine, tryptophan and methionine; and
a combination consisting of tryptophan and ornithine.

### Claim 2 (depends on 1)

The diagnostic marker according to claim 1, wherein the kidney disease is diabetic nephropathy.

### Claim 3 (depends on 1)

A computer program which is configured to cause a computer to operate the steps of:
obtaining a concentration of the diagnostic marker for kidney disease according to claim 1 in urine and/or plasma obtained from a subject suspected to have kidney disease;
determining whether or not the subject has the kidney disease based on the obtained concentration; and
delivering the result of determination.

### Claim 4 (depends on 3)

The computer program according to claim 3, which is configured to cause the computer to further operate the step of comparing the obtained concentration of the marker obtained in the obtaining step with a threshold, wherein
the obtaining step is the step of obtaining a value of the concentration of at least one marker selected from glycolic acid, N5-[(dimethylamino)iminomethyl]-ornithine and 5-oxo-2-tetrahydrofuran carboxylic acid in urine or plasma obtained from the subject suspected to have kidney disease and
the determining step is the step of determining whether or not the subject has kidney disease based on the comparison result obtained in the comparing step.

### Claim 5 (depends on 3)

The computer program according to claim 3, which is configured to cause the computer to further operate the steps of calculating a value relating to a ratio between the concentrations of the marker in urine and plasma from values of the concentrations of the marker in urine and plasma obtained in the obtaining step, and comparing the calculated value relating to the ratio between the concentrations of the marker in urine and plasma with a threshold, wherein
the obtaining step is the step of obtaining the value of a concentration of at least one substance selected from glycolic acid, N5-[(dimethylamino)iminomethyl]-ornithine and 5-oxo-2-tetrahydrofuran carboxylic acid in urine and plasma obtained from the subject suspected to have kidney disease and
the determining step is the step of determining whether or not the subject has kidney disease based on the comparison result obtained in the comparing step.

### Claim 6 (depends on 3)

The computer program according to claim 3, which is configured to cause the computer to further operate the steps of calculating a value relating to a ratio between the concentration of one substance and the concentration of the other substance in the diagnostic marker for kidney disease that consists of a combination of two substances from the concentrations of the two substances in urine and/or plasma obtained in the obtaining step, and comparing the calculated value relating to the ratio between the concentrations of two substances with a threshold, wherein
the obtaining step is the step of obtaining a value of the concentration of at least one marker selected from the diagnostic markers for kidney disease consisting of a combination of two substances in urine and plasma obtained from the subject suspected to have kidney disease and
the determining step is the step of determining whether or not the subject has kidney disease based on the comparison result obtained in the comparing step.

### Claim 7 (depends on 6)

The computer program according to claim 6, wherein the diagnostic markers for kidney disease is a combination of trimethylglycine with N5-[(dimethylamino)iminomethyl]-ornithine or guanidinoacetic acid.