Methods and compositions for evaluation and treatment of renal injury and renal failure based on C-C motif chemokine ligand 14 measurement

Patent metadata

Field	Value
Publication number	US-12203944-B2
Application number	US-202217739009-A
Country	US
Kind code	B2
Filing date	May 6, 2022
Priority date	Jan 12, 2017
Publication date	Jan 21, 2025
Grant date	Jan 21, 2025

Abstract

The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects suffering from or suspected of having a renal injury. In particular, the invention relates to using assays that detect C-C motif chemokine 14 as diagnostic and prognostic biomarker assays in renal injuries.

First claim

We claim:

1. A method for evaluating renal status in a subject that is diagnosed as having an acute kidney injury (AKI), wherein the subject meets the definition RIFLE I or F or KDIGO Stage 2 or 3, and treating the subject based on the evaluation, the method comprising:
(a) performing an assay configured to detect C-C motif chemokine 14 on a body fluid sample obtained from the subject to provide an assay result indicating a level of C-C motif chemokine 14 in the sample;
(b) determining that the subject is likely to respond favorably to diuretic treatment when the level of C-C motif chemokine 14 in the sample is below a predetermined threshold; and
(c) treating the subject having the level of C-C motif chemokine 14 below the predetermined threshold with diuretic therapy.

2. The method of claim 1 , wherein the body fluid is urine, blood, serum, or plasma.

3. The method of claim 2 , wherein said assay result is a measured urine concentration of C-C motif chemokine 14.

4. The method of claim 1 , wherein the subject is diagnosed as having an acute kidney injury meeting the definition RIFLE F or KDIGO Stage 3 at the time the time the body fluid sample is obtained.

5. A method for evaluating renal status in a subject and treating the subject based on the evaluation, comprising:
(a) selecting the subject for evaluation based on a measured value of one or more AKI biomarkers that exceeds a threshold indicative of an increased risk of having an acute kidney injury that meets the definition RIFLE I or F or KDIGO Stage 2 or 3;
(b) performing an assay configured to detect C-C motif chemokine 14 on a body fluid sample obtained from the subject to provide an assay result indicating a level of C-C motif chemokine 14 in the sample;
(c) determining that the subject is likely to respond favorably to diuretic treatment when the level of C-C motif chemokine 14 in the sample is below a predetermined threshold; and
(d) treating the subject having the level of C-C motif chemokine 14 below the predetermined threshold with diuretic therapy.

6. The method of claim 5 , wherein the AKI biomarkers are one or more of Insulin-like growth factor-binding protein 7, Metalloproteinase inhibitor 2, Neutrophil gelatinase-associated lipocalin, Cystatin-C, Interleukin-18, Hepatitis A virus cellular receptor 1, Glutathione S-transferase P, Creatinine, and Fatty acid-binding protein, liver, including combinations thereof.

7. The method of claim 5 , wherein the body fluid is urine, blood, serum, or plasma.

8. The method of claim 7 , wherein said assay result is a measured urine concentration of C-C motif chemokine 14.

9. The method of claim 5 , wherein the subject is diagnosed as having an acute kidney injury meeting the definition RIFLE F or KDIGO Stage 3 at the time the time the body fluid sample is obtained.

10. The method of claim 1 , wherein the assay result is a measured concentration of C-C motif chemokine 14.

11. The method of claim 1 , wherein the method further comprises contacting all or a portion of the body fluid sample with a binding reagent that specifically binds to C-C motif chemokine 14.

12. The method of claim 11 , wherein the binding reagent is an antibody.

13. The method of claim 1 , wherein the assay is an immunoassay.

14. The method of claim 13 , wherein the assay is a sandwich immunoassay.

15. The method of claim 1 , wherein the assay is a competitive binding assay.

16. The method of claim 5 , wherein the assay result is a measured concentration of C-C motif chemokine 14.

17. The method of claim 5 , wherein the method further comprises contacting all or a portion of the body fluid sample with a binding reagent that specifically binds to C-C motif chemokine 14.

18. The method of claim 17 , wherein the binding reagent is an antibody.

19. The method of claim 5 , wherein the assay is an immunoassay.

20. The method of claim 19 , wherein the assay is a sandwich immunoassay.

21. The method of claim 5 , wherein the assay is a competitive binding assay.

Assignees

• Astute Medical Inc

Inventors

• Kampf James Patrick
• Mcpherson Paul
• Chalfin Donald

Classifications

• G01N2800/56

  Staging of a disease; Further complications associated with the disease · CPC title

• G01N2800/347

  Renal failures; Glomerular diseases; Tubulointerstitial diseases, e.g. nephritic syndrome, glomerulonephritis; Renovascular diseases, e.g. renal artery occlusion, nephropathy · CPC title

• G01N2333/521

  Chemokines · CPC title

• G01N2800/52

  Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis · CPC title

• G01N33/53

  Immunoassay; Biospecific binding assay; Materials therefor · CPC title