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

Patent metadata

Field	Value
Publication number	US-11333671-B2
Application number	US-201515520817-A
Country	US
Kind code	B2
Filing date	Oct 20, 2015
Priority date	Oct 20, 2014
Publication date	May 17, 2022
Grant date	May 17, 2022

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 16, C—C motif chemokine 14, and Tyrosine-protein kinase receptor UFO as diagnostic and prognostic biomarker assays in renal injuries.

First claim

What is claimed is:

1. A method of detecting C—C motif chemokine 14 in a subject having acute kidney injury, the method comprising:
(a) obtaining a urine sample from the subject; and
(b) performing an assay to detect the level of C—C motif chemokine 14 in the urine sample.

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

3. The method of claim 2 , wherein the binding reagent is an antibody.

4. The method of claim 1 , wherein the subject has been diagnosed with one or more of congestive heart failure, preeclampsia, eclampsia, diabetes mellitus, hypertension, coronary artery disease, proteinuria, renal insufficiency, glomerular filtration below the normal range, cirrhosis, serum creatinine above the normal range, sepsis, injury to renal function, or reduced renal function.

5. The method of claim 1 , wherein the subject is undergoing or has undergone major vascular surgery, coronary artery bypass, or other cardiac surgery.

6. The method of claim 1 , wherein the subject has been exposed to NSAIDs, cyclosporines, tacrolimus, aminoglycosides, foscarnet, ethylene glycol, hemoglobin, myoglobin, ifosfamide, heavy metals, methotrexate, radiopaque contrast agents, or streptozotocin.

7. The method of claim 1 , wherein the subject is in RIFLE stage R.

8. The method of claim 1 , wherein the subject is in RIFLE stage I.

9. The method of claim 1 , wherein the subject is in RIFLE stage F.

10. The method of claim 1 , wherein the subject has a urine output of less than 0.5 ml/kg/hr over a 6-hour period.

11. The method of claim 1 , wherein the subject has a 1.5-fold or greater increase in serum creatinine from baseline.

12. The method of claim 1 , wherein the subject has an increase of 0.3 mg/dL or greater in serum creatinine.

13. The method of claim 1 , wherein the subject has a urine output of less than 0.5 ml/kg/hr over a 12-hour period.

14. The method of claim 1 , wherein the subject has a 2-fold or greater increase in serum creatinine from baseline.

15. The method of claim 1 , wherein the subject has a urine output of less than 0.3 ml/kg/hr over a 24-hour period.

16. The method of claim 1 , wherein the subject has anuria over a 12-hour period.

17. The method of claim 1 , wherein the subject has a 3-fold or greater increase in serum creatinine from baseline.

18. The method of claim 1 , wherein the subject has an increase in serum creatinine to 354 μmol/L or greater.

19. The method of claim 1 , wherein the subject has a 1.5-fold or greater increase in serum creatinine from baseline, an increase of 0.3 mg/dL or greater in serum creatinine, or a urine output of less than 0.5 ml/kg/hr over a 6-hour period.

20. The method of claim 1 , wherein the subject has a 2-fold or greater increase in serum creatinine from baseline or a urine output of less than 0.5 ml/kg/hr over a 12-hour period.

21. The method of claim 1 , wherein the subject has a 3-fold or greater increase in serum creatinine from baseline, an increase in serum creatinine to 354 μmol/L or greater, a urine output of less than 0.3 ml/kg/hr over a 24-hour period, or anuria over a 12-hour period.

Assignees

• Astute Medical Inc

Inventors

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

Classifications

• G01N2333/521

  Chemokines · CPC title

• G01N2333/71

  for growth factors; for growth regulators · CPC title

• G01N33/6872

  Intracellular protein regulatory factors and their receptors, e.g. including ion channels · CPC title

• G01N33/6893 Primary

  related to diseases not provided for elsewhere · CPC title

• G01N33/6863 Primary

  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 · CPC title