IP Library Granted Patent US 10,078,089
Granted Patent B2
US 10,078,089 · App. 14/838,551 · Granted Sep 18, 2018

Compositions and methods for treating steroid resistant nephrotic syndrome and/or steroid sensitive nephrotic syndrome

Inventors: Michael R. Bennett (Independence, KY); Prasad Devarajan (Cincinnati, OH)
Assignee: Children's Hospital Medical Center
G01N33/6893C12Q1/6883G06F19/20G06F19/24C12Q2600/158G01N2800/347
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Quick Facts
Patent No.
US 10,078,089
App. No.
14/838,551
Granted
Sep 18, 2018
Kind
B2
Abstract

Disclosed are methods of determining whether a patient diagnosed with nephrotic syndrome has steroid sensitive nephrotic syndrome (SSNS) or steroid resistant nephrotic syndrome (SRNS) by determining the levels of one or more biomarkers in a biofluid from the patient. Also disclosed are methods of treating a patient diagnosed with nephrotic syndrome, and kits and substrates related to the disclosed methods.

Claims (13)

1. A method of diagnosing and treating a subject having a nephrotic syndrome with either steroid resistant (SRNS) or steroid sensitive nephrotic syndrome (SSNS), comprising the step of contacting a urine sample obtained from said subject with a combination of antibodies;

wherein said combination of antibodies comprises an antibody capable of detecting Vitamin D-binding protein (VDBP), an antibody capable of detecting Neutrophil gelatinase-associated lipocalin (NGAL), and an antibody capable of detecting Fetuin A;

wherein said combination of antibodies is used to determine the amount of VDBP, NGAL, and Fetuin A in said urine sample;

wherein an increase in the amount of VDBP, NGAL, and Fetuin A in said urine sample as compared to a cut-off value, indicates that said subject is steroid resistant;

wherein a decrease in the amount of VDBP, NGAL, and Fetuin A in said urine sample as compared to a cut-off value, indicates that said subject is steroid sensitive; and

treating said steroid resistant subject with a non-steroid based therapy or said steroid sensitive subject with a steroid based therapy.

2. The method of claim 1 , wherein said combination of antibodies further comprise an antibody capable of detecting alpha-1-acid glycoprotein 2 (AGP2), wherein a decrease in AGP2 levels indicate that said patient is steroid sensitive, and an increase in AGP2 levels indicate that said patient is steroid resistant.

3. The method of claim 1 , wherein said combination of antibodies further comprise an antibody capable of detecting prealbumin, wherein a decrease in prealbumin levels indicate that said patient is steroid sensitive, and an increase in prealbumin levels indicate that said patient is steroid resistant.

4. A computerized method for characterizing a subject as having either steroid resistant nephrotic syndrome (SRNS) or steroid sensitive nephrotic syndrome (SSNS), comprising analyzing, using a processor, an expression profile representing the normalized expression levels of genes in a blood sample of said individual by subjecting said expression profile to a formula based on a statistical analysis of known expression profiles, said known expression profiles representing the normalized expression level of each one of said genes in said subject and in one or more control individuals, thereby obtaining a value corresponding to the probability that the tested individual has either SRNS or SSNS, wherein said genes comprise Vitamin D-binding protein (VDBP), Neutrophil gelatinase-associated lipocalin (NGAL), and Fetuin A, wherein a detected decrease in said genes indicates that said subject has steroid sensitive nephrotic syndrome and wherein a detected increase in said genes indicates that said subject has steroid resistant steroid syndrome.

5. A kit comprising a combination of antibodies capable of binding to Vitamin D-binding protein (VDBP), Neutrophil gelatinase-associated lipocalin (NGAL), and Fetuin A.

6. The kit of claim 5 , further comprising an antibody capable of detecting alpha-1-acid glycoprotein 2 (AGP2), and an antibody capable of detecting prealbumin.

7. A substrate comprising a combination of antibodies capable of binding to Vitamin D-binding protein (VDBP), Neutrophil gelatinase-associated lipocalin (NGAL), and Fetuin A.

8. The substrate of claim 7 , further comprising an antibody capable of binding to albumin and an antibody capable of binding to alpha-1-acid glycoprotein 2 (AGP2).

Assignments (2)
CONFIRMATORY LICENSE Recorded Dec 1, 2016
From: CINCINNATI CHILDRENS HOSP MED CTR
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 040787/0704 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 4, 2015
From: BENNETT, MICHAEL; DEVARAJAN, PRASAD
To: CHILDREN'S HOSPITAL MEDICAL CENTER
Reel/Frame 036493/0160 →
Continuity (2)
Provisional Application 62043805 · Aug 29, 2014
Related Publication 20160061845A1 · Mar 3, 2016