Methods and compositions for diagnosis and prognosis of renal injury and renal failure

Patent metadata

Field	Value
Publication number	US-11209443-B2
Application number	US-201916679486-A
Country	US
Kind code	B2
Filing date	Nov 11, 2019
Priority date	Dec 18, 2014
Publication date	Dec 28, 2021
Grant date	Dec 28, 2021

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 Chitinase-3-like protein 1 as diagnostic and prognostic biomarker assays in renal injuries.

First claim

We claim:

1. A method of treating a subject having acute kidney injury, the method comprising:
performing an assay configured to detect Chitinase-3-like protein 1 in a body fluid sample obtained from the subject to provide an assay result;
correlating the assay result to an increased likelihood of the subject having persistent RIFLE stage F acute kidney injury, wherein persistent RIFLE stage F acute kidney injury is defined as the subject having a minimum RIFLE stage of F over a period of at least 24 hours beginning within 7 days after the sample was obtained, by:
comparing the assay result to a threshold value obtained from a population study, wherein the threshold separates the population into a first subpopulation above the threshold and a second subpopulation at or below the threshold, the first subpopulation being at an increased likelihood of having persistent RIFLE stage F acute kidney injury relative to the second subpopulation, and
assigning the subject to the first subpopulation; and

treating the subject for persistent acute kidney injury, wherein the treatment comprises renal replacement therapy, withdrawing delivery of compounds that are known to be damaging to the kidney, delaying procedures that are known to be damaging to the kidney, or modifying diuretic administration.

2. The method of claim 1 , wherein the assay result comprises a measured concentration of Chitinase-3-like protein 1.

3. The method of claim 1 , wherein the sample is a urine sample.

4. The method of claim 1 , wherein the subject is in RIFLE stage F acute kidney injury when the sample is obtained.

5. The method of claim 1 , wherein the period is at least 48 hours long.

6. The method of claim 1 , wherein the subject is in RIFLE stage I or F acute kidney injury when the sample is obtained, wherein the period is at least 72 hours long, and wherein the period starts within 48 hours after the sample is obtained.

7. The method of claim 1 , wherein the period starts at least 72 hours after the sample is obtained.

8. A method of treating a subject having RIFLE stage F acute kidney injury, the method comprising:
performing an assay configured to detect Chitinase-3-like protein 1 in a body fluid sample obtained from the subject to provide an assay result;
correlating the assay result to a decreased likelihood of recovery from acute kidney injury, wherein recovery is defined as the subject having a maximum RIFLE stage of I over a period of at least 24 hours beginning within 7 days after the sample was obtained, by:
comparing the assay result to a threshold value obtained from a population study, wherein the threshold separates the population into a first subpopulation above the threshold and a second subpopulation at or below the threshold, the second subpopulation having an increased likelihood of recovering from RIFLE stage F acute kidney injury relative to the first subpopulation, and
assigning the subject to the first subpopulation; and

treating the subject for non-recovery from acute kidney injury, wherein the treatment comprises renal replacement therapy, withdrawing delivery of compounds that are known to be damaging to the kidney, delaying procedures that are known to be damaging to the kidney, or modifying diuretic administration.

9. The method of claim 8 , wherein recovery is further defined as the subject having a maximum RIFLE stage of 0 over the period of at least 24 hours.

10. The method of claim 8 , wherein the assay result comprises a measured concentration of Chitinase-3-like protein 1.

11. The method of claim 8 , wherein the sample is a urine sample.

12. The method of claim 8 , wherein the period is at least 48 hours long.

13. The method of claim 8 , wherein the period is at least 72 hours long, and wherein the period starts within 48 hours after the sample is obtained.

14. The method of claim 8 , wherein the period starts at least 72 hours after the sample is obtained.

15. A method of treating a subject having acute kidney injury, the method comprising:
performing an assay configured to detect Chitinase-3-like protein 1 in a body fluid sample obtained from the subject to provide an assay result;
correlating the assay result to an increased likelihood of the subject having persistent RIFLE stage R acute kidney injury, wherein persistent RIFLE stage R acute kidney injury is defined as the subject having a minimum RIFLE stage of R over a period of at least 24 hours beginning within 7 days after the sample was obtained, by:
comparing the assay result to a threshold value obtained from a population study, wherein the threshold separates the population into a first subpopulation above the threshold and a second subpopulation at or below the threshold, the first subpopulation being at an increased likelihood of having persistent RIFLE stage R acute kidney injury relative to the second subpopulation, and
assigning the subject to the first subpopulation; and

treating the subject for persistent acute kidney injury, wherein the treatment comprises renal replacement therapy, withdrawing delivery of compounds that are known to be damaging to the kidney, delaying procedures that are known to be damaging to the kidney, or modifying diuretic administration.

16. The method of claim 15 , wherein the assay result comprises a measured concentration of Chitinase-3-like protein 1.

17. The method of claim 15 , wherein the sample is a urine sample.

18. The method of claim 15 , wherein the subject is in RIFLE stage F acute kidney injury when the sample is obtained.

19. The method of claim 15 , wherein the period is at least 48 hours long.

20. The method of claim 15 , wherein the period is at least 72 hours long.

Assignees

• Astute Medical Inc

Inventors

• Anderberg Joseph
• Gray Jeff
• Mcpherson Paul
• Nakamura Kevin
• Kampf James Patrick

Classifications

• G01N2333/4724

  Lectins · CPC title

• G01N2030/8813

  biological materials · 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

• G01N33/6893 Primary

  related to diseases not provided for elsewhere · CPC title