Diagnostic Test to Exclude Significant Renal Injury

• US 20100210031A2
• Filed: 08/03/2007
• Published: 08/19/2010
• Est. Priority Date: 08/07/2006
• Status: Abandoned Application

• Current Assignee: AntibodyShop A/S
• Original Assignee: AntibodyShop A/S
• Inventors: Uttenthal, Lars, Bangert, Kristian
• Application Number:
  US12/375,585
• Publication Number:
  US 20090311801A1
• Time in Patent Office: Days
• US Class Current: 436/501
• CPC Class Codes: G01N 2800/347 Renal failures; Glomerular diseases; Tubulointerstitial diseases, e.g. nephritic syndrome, glomerulonephritis; Renovascular diseases, e.g. renal artery occlusion, nephropathy
• CPC Class Codes: G01N 2800/7095 Inflammation
• CPC Class Codes: G01N 33/68 involving proteins, peptides or amino acids involving lipoproteins G01N33/92
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere

Abstract

Methods for determining the risk of developing acute renal failure in a human subject by measuring human neutrophil gelatinase-associated lipocalin (NGAL) are provided.

Claims

1. A method of diagnosing, monitoring or determining the risk of developing acute renal failure in a human subject, wherein said method discriminates between a subject who does not have acute renal failure and is not at immediate risk of developing acute renal failure, and a subject who may have acute renal failure or is at risk of developing acute renal failure, said method comprising the steps of

i) determining the concentration of human neutrophil gelatinase-associated lipocalin (NGAL) in a sample of bodily fluid from the subject, and

ii) comparing said concentration with a predetermined cutoff value chosen so that an NGAL concentration below the cutoff value categorizes the subject as not having and not being at immediate risk of developing acute renal failure.

2. The method of claim 1, wherein the sample is a urine sample and the cutoff value is a concentration of 250 ng/mL or a lower value, such any value between 250 ng/mL and 200 ng/mL, such as 225 ng/mL, or any value between 200 ng/mL and 150 ng/mL, such as 175 ng/mL or 160 ng/mL or 155 ng/mL, or any value between 150 ng/mL and 100 ng/mL, such as 125 ng/mL, or any value between 100 ng/mL and 50 ng/mL, such as 75 ng/mL.

3. The method of claim 1, wherein the sample is a plasma or serum sample and the cutoff value is 250 ng/mL or a lower value, such any value between 250 ng/mL and 200 ng/mL, such as 225 ng/mL, or any value between 200 ng/mL and 150 ng/mL, such as 175 ng/mL or 160 ng/mL or 155 ng/mL, or any value between 150 ng/mL and 100 ng/mL, such as 125 ng/mL.

4. The monitoring method of any of the preceding claims, comprising the further step of repeating steps i) and ii) of claim 1 one or more times.

5. The monitoring method of any of the preceding claims, comprising the further step of repeating steps i) and ii) of claim 1 within 24 hours, e.g. within 12 hours, such as within 6 hours, e.g. within 3 hours, such as within 1 hour, e.g. within 30 minutes.

6. The monitoring method of any of the preceding claims, comprising the further step of repeating steps i) and ii) of claim 1 after a treatment of acute renal failure has been initiated or completed.

7. The method of any of the preceding claims, wherein the risk of developing acute renal failure is due to ischemic renal injury.

8. The method of any of the preceding claims, wherein the risk of developing acute renal failure is due to a complication of an inflammatory, infective or neoplastic disease.

9. The method of any of the preceding claims, wherein the risk of developing acute renal failure is due to critical illness of any cause requiring intensive care.

10. The method of any of the preceding claims, wherein the risk of developing acute renal failure is due to a surgical intervention.

11. The method of any of the preceding claims, wherein the risk of developing acute renal failure is due to the administration of a nephrotoxic agent.

12. The method of any of the preceding claims, wherein NGAL is measured by means of a molecule that binds specifically to NGAL.

13. The method of any of the preceding claims, wherein the bodily fluid is urine.

14. The method of any of the preceding claims, wherein the bodily fluid is blood or plasma or serum.