IP Library › Granted Patent US 12,203,944
Granted Patent B2
US 12,203,944 · App. 17/739,009 · Granted Jan 21, 2025

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

Inventors: James Patrick Kampf (San Diego, CA); Paul McPherson (Encinitas, CA); Donald Chalfin (Berkeley, CA)
Assignee: Astute Medical, Inc.
G01N33/6893G01N2333/521G01N2800/347G01N2800/56
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Quick Facts
Patent No.
US 12,203,944
App. No.
17/739,009
Granted
Jan 21, 2025
Kind
B2
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.

Claims (28)

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.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 8, 2025
From: ASTUTE MEDICAL, INC.
To: BIOMERIEUX, INC.
Reel/Frame 069778/0363 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 10, 2022
From: KAMPF, JAMES PATRICK; MCPHERSON, PAUL; CHALFIN, DONALD
To: ASTUTE MEDICAL, INC.
Reel/Frame 059882/0868 →
Continuity (3)
Continuation 16475326
Provisional Application 62445692 · Jan 12, 2017
Related Publication 20230025225A1 · Jan 26, 2023
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