IP Library › Granted Patent US 8,440,463
Granted Patent B2
US 8,440,463 · App. 12/909,140 · Granted May 14, 2013

Predicting renal failure in diabetes patients based on placental growth factor and soluble FLT-1

Inventors: Georg Hess (Mainz, DE); Andrea Horsch (Mannheim, DE); Dietmar Zdunek (Tutzing, DE)
Assignee: Roche Diagnostics Operations, Inc.
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Quick Facts
Patent No.
US 8,440,463
App. No.
12/909,140
Granted
May 14, 2013
Kind
B2
Abstract

Disclosed is a method for predicting the risk of developing renal failure or mortality for a subject suffering from diabetes mellitus. More specifically, a method is disclosed for predicting the risk of developing renal failure for a subject suffering from diabetes mellitus, the method including the steps of determining the amounts of PLGF and sFlt-1 in a sample of a subject suffering from diabetes mellitus and comparing the amounts of PLGF and sFlt-1 determined with reference amounts of PLGF and sFlt-1, whereby the risk of developing renal failure is predicted. Also disclosed are diagnostic devices and kits for carrying out the aforementioned methods.

Claims (37)

1. A method for predicting a risk of developing chronic renal insufficiency in a subject suffering from diabetes mellitus type I, the method comprising:

(a) contacting a sample from the subjects with a ligand specific for placental growth factor (PLGF);

(b) calculating an amount of PLGF in the sample based contacting step (a);

(c) contacting a sample from the subject with a ligand specific for soluble Flt-1 (sFlt-1);

(d) calculating an amount of sFlt-1 in the sample based contacting of step (c)

comparing the calculated amount of PLGF and the calculated amount of sFlt-1 with a reference amount of PLGF and a reference amount of sFlt-1, respectively; and

predicting a risk of developing chronic renal insufficiency if the calculated amount of PLGF is greater than a reference amount of PLGF between 12 and 15 pg/ml and the calculated amount of sFlt-1 is greater than a reference amount of sFlt-1 between 90 and 120 pg/ml.

2. The method of claim 1 , wherein the reference amount of PLGF is 13 pg/ml and the reference amount of sFlt-1 is 95 pg/ml.

3. A method for determining susceptibility of a subject to a renal therapy wherein the subject suffers from diabetes mellitus type I, the method comprising:

(a) contacting a sample from the subject with a ligand specific for placental growth factor (PLGF)

(b) calculating an amount of PLGF in the sample based on contacting step (a);

(c) contacting a sample from the subject with a ligand specific for soluble Flt-1 (sFlt-1);

(d) calculating an amount of sFlt-1 in the sample based on contacting step (c); and

assessing the subject as susceptible to renal therapy if

the calculated amount of PLGF is greater than a reference amount of PLGF between 12 and 15 pg/ml and the calculated amount of sFlt-1 is greater than a reference amount of sFlt-1 between 90 and 120 pg/ml.

4. The method of claim 3 , wherein the reference amount of PLGF is 13 pg/ml and the reference amount of sFlt-1 is 95 pg/ml.

5. The method of claim 3 , wherein the renal therapy is selected from the group consisting of blood pressure lowering drugs, aspirin, statins, angiotensin-converting enzyme (ACE) inhibitors, and angiotensin II receptor blockers.

6. A method for predicting a risk of mortality in a subject suffering from diabetes mellitus type I, the method comprising:

(a) contacting a sample from the subject with a ligand specific for placental growth factor (PLGF);

(b) calculating an amount of PLGF in the sample based on contacting step (a);

(c) contacting a sample from the subject with a ligand specific for soluble Flt-1 (sFlt-1);

(d) calculating an amount of sFlt-1 in the sample based on contacting step (c); and

predicting an increased risk of mortality if the calculated amount of PLGF is greater than a reference amount of PLGF between 12 and 15 pg/ml and the calculated amount of sFlt-1 is greater than a reference amount of sFlt-1 between 90 and 120 pg/ml.

7. The method of claim 6 , wherein the reference amount of PLGF is 13 pg/ml and the reference amount of sFlt-1 is 95 pg/ml.

8. The method according to claim 1 wherein the subject suffering from diabetes mellitus type I is apparently healthy with respect to kidney function.

9. The method according to claim 3 wherein the subject suffering from diabetes mellitus type I is apparently healthy with respect to kidney function.

10. The method according to claim 6 wherein the subject suffering from diabetes mellitus type I is apparently healthy with respect to kidney function.

11. The method according to claim 1 wherein predicting a risk of developing chronic renal insufficiency comprises a predictive window of at least 12 years.

12. The method according to claim 6 wherein predicting a risk of mortality comprises a predictive window of at least 12 years.

13. A method for managing treatment of a patient determining susceptibility suffering from diabetes mellitus type I, the method comprising:

determining susceptibility of the patient for a renal therapy by

(a) contacting a sample from the subject with a ligand specific for placental growth factor (PLGF),

(b) calculating an amount of PLGF in the sample based on contacting step (a),

(c) contacting a sample from the subject with a ligand specific for soluble Flt-1 (sFlt-1),

(d) calculating an amount of sFlt-1 in the sample based on contacting step (c),

assessing the subject as susceptible to renal therapy if the calculated amount of PLGF is greater than a reference amount of PLGF between 12 and 15 pg/ml and the calculated amount of sFlt-1 is greater than a reference amount of sFlt-1between 90 and 120 pg/ml; and

initiating a treatment for renal insufficiency if the patient is susceptible to renal therapy, wherein the treatment comprises administration of blood pressure lowering drugs, aspirin, statins, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers or combinations thereof.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 18, 2010
From: HESS, GEORG; HORSCH, ANDREA; ZDUNEK, DIETMAR
To: ROCHE DIAGNOSTICS GMBH
Reel/Frame 025373/0880 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 18, 2010
From: ROCHE DIAGNOSTICS GMBH
To: ROCHE DIAGNOSTICS OPERATIONS, INC.
Reel/Frame 025373/0911 →
Priority Claims (1)
EP 08156083 · May 13, 2008 · regional
Continuity (2)
Continuation PCTEP2009055595 · May 8, 2009
Related Publication 20110033942A1 · Feb 10, 2011