# US 2016/0252528 A1 · Assessing renal structural alterations and outcomes

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- Number: US 2016/0252528 A1
- Document ID: US20160252528A1
- Status: Published application
- Kind: A1
- Application number: 15/078,835
- Filed: 2016-03-23
- Published: 2016-09-01
- Earliest claimed: 2011-12-23
- Assignees: Mayo Foundation for Medical Education and Research
- Applicants: Mayo Foundation for Medical Education and Research
- Inventors: Sasantha J. Sangaralingham; John C. Burnett, JR.; Alessandro Cataliotti; Denise M. Heublein
- Web page: https://patentgrep.com/patent/US20160252528A1

## CPC

- G01N 33/6893: {related to diseases not provided for elsewhere}
- A61K 38/2242: {Atrial natriuretic factor complex: Atriopeptins, atrial natriuretic protein [ANP]; Cardionatrin, Cardiodilatin}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- C07K 14/58: Atrial natriuretic factor complex; Atriopeptin; Atrial natriuretic peptide [ANP]; Cardionatrin; Cardiodilatin
- G01N 2333/58: Atrial natriuretic factor complex; Atriopeptin; Atrial natriuretic peptide [ANP]; Brain natriuretic peptide [BNP, proBNP]; Cardionatrin; Cardiodilatin
- G01N 2800/04: Endocrine or metabolic disorders
- G01N 2800/042: Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism
- G01N 2800/32: Cardiovascular disorders
- G01N 2800/324: Coronary artery diseases, e.g. angina pectoris, myocardial infarction
- G01N 2800/325: Heart failure or cardiac arrest, e.g. cardiomyopathy, congestive heart failure
- G01N 2800/347: Renal failures; Glomerular diseases; Tubulointerstitial diseases, e.g. nephritic syndrome, glomerulonephritis; Renovascular diseases, e.g. renal artery occlusion, nephropathy
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- G01N 2800/56: Staging of a disease; Further complications associated with the disease
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)

## Abstract

This document provides methods and materials involved in assessing renal structural alterations (e.g., renal fibrosis, glomerular basement thickening, mesangial matrix expansion, swollen podocytes, and foot processes effacement) as well as methods and materials involved in assessing outcomes. For example, methods and materials for using the level of urinary CNP (e.g., a urinary to plasma CNP ratio) to determine whether or not a mammal is developing renal structural alterations (e.g., renal fibrosis, glomerular basement thickening, mesangial matrix expansion, swollen podocytes, and foot processes effacement) as well as methods and materials for using the level of urinary CNP levels to identify patients having an increased likelihood of experiencing a poor outcome are provided.

## Claims

### Claim 1

(canceled)

### Claim 2

A method for treating a mammal having an increased risk of a poor outcome, wherein said method comprises:
(a) determining that said mammal has an elevated level of urinary NT-CNP-53,
(b) monitoring said mammal for the presence of a risk factor for a poor outcome, and
(c) instructing said mammal to administer a therapeutic agent to reduce the likelihood of said poor outcome.

### Claim 3 (depends on 2)

The method of claim 2, wherein said mammal is a human.

### Claim 4 (depends on 2)

The method of claim 2, wherein said elevated level is greater than 36,000 pg of NT-CNP-53/day.

### Claim 5 (depends on 2)

The method of claim 2, wherein said elevated level is greater than 42,000 pg of NT-CNP-53/day.

### Claim 6 (depends on 2)

The method of claim 2, wherein said risk factor is selected from the group consisting of an age factor, hypertension, an elevated serum creatinine level, proteinuria, an elevated body mass index, an elevated cholesterol level, a smoking habit, and diabetes.

### Claim 7 (depends on 2)

The method of claim 2, wherein said therapeutic agent is an ACE inhibitor, an angiotensin receptor blocker, an aldosterone antagonist, a statin, a native natriuretic peptide, or a designer natriuretic peptide.