IP Library Granted Patent US 9,816,985
Granted Patent B2
US 9,816,985 · App. 14/394,965 · Granted Nov 14, 2017

Method for predicting risk of exposure to interstitial fibrosis and tubular atrophy with clusterin

Inventors: Barbara Murphy (Pelham Manor, NY); Philip J. O'Connell (Sydney, AU)
Assignees: Icahn School of Medicine at Mount Sinai; Westmead Institure For Medical Research; Western Sydney Local Health District
G01N33/5308G01N33/6893C07K14/47G01N2333/775G01N2800/085G01N2800/245G01N2800/50G01N2800/54
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Quick Facts
Patent No.
US 9,816,985
App. No.
14/394,965
Granted
Nov 14, 2017
Kind
B2
Abstract

A method for identifying a kidney transplant recipient at an increased risk of developing interstitial fibrosis or tubular atrophy which comprises obtaining a post-transplant urine sample from the kidney transplant recipient; measuring the level of clusterin in the urine sample; comparing the level of clusterin in the patient sample to the level of clusterin in a control sample from the urine of a non-fibrotic kidney transplant recipient; diagnosing a kidney transplant recipient with a clusterin level that is significantly higher than the clusterin level in the control as being at an increased risk of developing interstitial fibrosis or tubular atrophy.

Claims (27)

1. A method for treating a kidney transplant recipient at an increased risk of developing interstitial fibrosis or tubular atrophy which comprises:

obtaining a post-transplant urine sample from the kidney transplant recipient;

measuring the level of clusterin in the urine sample;

comparing the level of clusterin in the patient sample to the level of clusterin in a control sample from the urine of a non-fibrotic kidney transplant recipient;

diagnosing a kidney transplant recipient with a clusterin level that is significantly higher than the clusterin level in the control as being at an increased risk of developing interstitial fibrosis or tubular atrophy and

treating the recipient for interstitial fibrosis or tubular atrophy.

2. The method of claim 1 wherein the treatment comprises administering an anti-fibrotic agent to the recipient identified as being at increased risk of developing interstitial fibrosis or tubular atrophy.

3. The method of claim 2 wherein the anti-fibrotic agent is a member selected from the group consisting of Pirfenidone, Relaxin, Bone morphogenetic protein 7 (BMP-7), Hepatocyte growth factor (HGF), and Epoetin delta.

4. The method of claim 1 comprising administering an angiotensin converting enzyme inhibitor (ACEI) to the recipient identified as being at increased risk of developing interstitial fibrosis or tubular atrophy.

5. The method of claim 1 comprising administering an angiotensin II receptor antagonist to the kidney transplant recipient identified as being at increased risk of developing interstitial fibrosis or tubular atrophy.

6. The method of claim 5 wherein said angiotensin II receptor antagonist is losartan.

7. The method of claim 1 comprising administering an immunosuppressive drug to the recipient identified as being at increased risk of developing interstitial fibrosis or tubular atrophy.

8. The method of claim 7 wherein said immunosuppressive drug is a member selected from the group consisting of cyclosporine, tacrolimus, mycophenolate mofetil (MMF) and sirolimus.

9. A method for treating a kidney transplant recipient at an increased risk of developing tubular atrophy which comprises:

obtaining a post-transplant urine sample from the kidney transplant recipient;

measuring the level of clusterin in the urine sample;

comparing the level of clusterin in the transplant recipient urine sample to the level of clusterin in a control sample from the urine of a kidney transplant recipient that is not afflicted with tubular atrophy;

diagnosing the kidney transplant recipient with a clusterin level that is significantly higher than the clusterin level in the control as being at an increased risk of developing tubular atrophy and treating the patient at an increased risk of developing tubular atrophy.

10. A method for treating a patient at increased risk of developing decreased renal function in a kidney transplant recipient which comprises the steps of:

obtaining a post-transplant urine sample from the kidney transplant recipient afflicted with tubular atrophy;

measuring the level of clusterin in the urine sample from the kidney transplant recipient that is afflicted with tubular atrophy;

comparing the level of clusterin in the sample from the kidney transplant recipient that is afflicted with tubular atrophy to the level of clusterin in a control urine sample from a non-fibrotic kidney transplant recipient;

diagnosing the kidney transplant recipient that is afflicted with tubular atrophy as being at an increased risk of developing decreased renal function if the clusterin level in said patient's urine sample is more than 50% higher than the clusterin level in the control and treating the patient diagnosed as being at increased risk of developing decreased renal function.

11. The method of claim 10 wherein the treatment comprises administering an anti-fibrotic agent to the recipient identified as being at increased risk of developing decreased renal function.

12. The method of claim 11 wherein the anti-fibrotic agent is a member selected from the group consisting of Pirfenidone, Relaxin, Bone morphogenetic protein 7 (BMP-7), Hepatocyte growth factor (HGF), and Epoetin delta.

13. The method of claim 10 comprising administering an angiotensin II receptor antagonist to the recipient identified as being at an increased risk of developing decreased renal function.

14. The method of claim 13 wherein the angiotensin II receptor antagonist is losartan.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 23, 2017
From: O'CONNELL, PHILIP J.
To: WESTERN SYDNEY LOCAL HEALTH DISTRICT; WESTMEAD INSTITUTE FOR MEDICAL RESEARCH
Reel/Frame 043365/0169 →
CONFIRMATORY LICENSE Recorded Jul 7, 2016
From: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 039276/0354 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 17, 2014
From: MURPHY, BARBARA
To: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
Reel/Frame 033970/0611 →
Continuity (2)
Provisional Application 61625636 · Apr 17, 2012
Related Publication 20150133378A1 · May 14, 2015