IP Library Granted Patent US 11,150,250
Granted Patent B2
US 11,150,250 · App. 13/061,413 · Granted Oct 19, 2021

Methods for diagnosing acute kidney injury or renal failure

Inventors: Joseph Anderberg (Encinitas, CA); Jeff Gray (Solana Beach, CA); Paul McPherson (Encinitas, CA); Kevin Nakamura (Cardiff by the Sea, CA)
Assignee: Astute Medical, Inc.
G01N33/6893G01N2800/347
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Quick Facts
Patent No.
US 11,150,250
App. No.
13/061,413
Granted
Oct 19, 2021
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 one or more markers selected from the group consisting of soluble p-selectin, protein NOV homolog, soluble epidermal growth factor receptor, netrin-4, haptoglobin, heat shock protein beta-1, alpha-1-antitrypsin, leukocyte elastase, soluble tumor necrosis factor receptor superfamily member 6, soluble tumor necrosis factor ligand superfamily member 6, soluble intercellular adhesion molecule 2, active caspase-3, and soluble platelet endothelial cell adhesion molecule as diagnostic and prognostic biomarkers in renal injuries.

Claims (13)

1. A method for evaluating a risk of future acute kidney injury in a subject and treating the subject based on the evaluation, the method comprising:

detecting soluble tumor necrosis factor receptor superfamily member 6 in a urine sample with an antibody which specifically binds to the soluble tumor necrosis factor receptor superfamily member 6 using an immunoassay; and generating an assay result indicative of binding of the soluble tumor necrosis factor receptor superfamily member 6 to the antibody;

correlating the assay result to an increased risk of the subject developing a future acute kidney injury meeting the definition of RIFLE I or F when the assay result is above a predetermined threshold value; and

treating the subject having the increased risk of developing a future acute kidney injury meeting the definition of RIFLE I or F with a compatible treatment regimen comprising one or more of initiating renal replacement therapy and withdrawing delivery of compounds that are known to be damaging to the kidney.

2. The method according to claim 1 , wherein said assay result comprises a measured concentration of the soluble tumor necrosis factor receptor superfamily member 6.

3. The method of claim 1 , wherein the treatment regimen comprises the renal replacement therapy.

4. The method of claim 3 , wherein the renal replacement therapy comprises hemodialysis, peritoneal dialysis, hemofiltration, and/or renal transplantation.

5. A method of treating a subject at increased risk of a future acute kidney injury, the method comprising:

determining the subject is at increased risk of a future acute kidney injury by performing an assay to detect soluble tumor necrosis factor receptor superfamily member 6 in a urine sample obtained from the subject, wherein the level of the soluble tumor necrosis factor receptor superfamily member 6 in the urine is above a predetermined threshold level; and

treating the subject having an increased risk of future acute kidney injury with a compatible treatment regimen comprising one or more of initiating renal replacement therapy and withdrawing delivery of compounds that are known to be damaging to the kidney.

6. The method of claim 5 , wherein the assay comprises (i) contacting the urine sample with an antibody which specifically binds soluble tumor necrosis factor receptor superfamily member 6, and (ii) generating an assay result indicative of binding of soluble tumor necrosis factor receptor superfamily member 6 to the antibody.

7. The method of claim 5 , wherein the treatment regimen comprises the renal replacement therapy.

8. The method of claim 7 , wherein the renal replacement therapy comprises hemodialysis, peritoneal dialysis, hemofiltration, and/or renal transplantation.

Assignments (3)
RELEASE OF SECURITY INTEREST Recorded May 4, 2018
From: CAPITAL ROYALTY PARTNERS II L.P.; CAPITAL ROYALTY PARTNERS II - PARALLEL FUND "A" L.P.; PARALLEL INVESTMENT OPPORTUNITIES PARTNERS II L.P.
To: ASTUTE MEDICAL, INC.
Reel/Frame 046077/0084 →
CORRECTIVE ASSIGNMENT TO CORRECT THE APPLICATION NUMBER 61831594 PREVIOUSLY RECORDED AT REEL: 032459 FRAME: 0246. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY AGREEMENT. Recorded Nov 12, 2015
From: ASTUTE MEDICAL, INC.
To: CAPITAL ROYALTY PARTNERS II L.P.; CAPITAL ROYALTY PARTNERS II - PARALLEL FUND "A" L.P.; PARALLEL INVESTMENT OPPORTUNITIES PARTNERS II L.P.
Reel/Frame 037207/0287 →
SECURITY INTEREST Recorded Mar 17, 2014
From: ASTUTE MEDICAL, INC.
To: CAPITAL ROYALTY PARTNERS II L.P.; CAPITAL ROYALTY PARTNERS II - PARALLEL FUND "A" L.P.; PARALLEL INVESTMENT OPPORTUNITIES PARTNERS II L.P.
Reel/Frame 032459/0246 →