Hepcidins as biomarkers for impending lupus nephritis flare

• US 8,313,950 B2
• Filed: 05/19/2008
• Issued: 11/20/2012
• Est. Priority Date: 05/21/2007
• Status: Expired due to Fees

• Current Assignee: The Ohio State University Research Foundation
• Original Assignee: The Ohio State University Research Foundation
• Inventors: Rovin, Brad H., Zhang, Xiaolan
• Primary Examiner(s): FOSTER, CHRISTINE E
• Application Number:
  US12/600,890
• Publication Number:
  US 20100151487A1
• Time in Patent Office: 1,646 Days
• Field of Search: None
• US Class Current: 436/86
• CPC Class Codes: G01N 2800/104 Lupus erythematosus [SLE]
• CPC Class Codes: G01N 2800/347 Renal failures; Glomerular diseases; Tubulointerstitial diseases, e.g. nephritic syndrome, glomerulonephritis; Renovascular diseases, e.g. renal artery occlusion, nephropathy
• CPC Class Codes: G01N 2800/50 Determining the risk of developing a disease
• CPC Class Codes: G01N 2800/56 Staging of a disease; Further complications associated with the disease
• CPC Class Codes: G01N 33/53 Immunoassay; Biospecific binding assay; Materials therefor
• CPC Class Codes: G01N 33/564 for pre-existing immune complex or autoimmune disease , i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9
• CPC Class Codes: G01N 33/74 involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors

Abstract

Biomarkers for determining a kidney flare episode in systemic lupus erythematosus are described.

Claims

1. A method of analyzing a subject sample to identify at least a beginning of a kidney flare episode in a subject suffering from systemic lupus erythematosus (SLE), comprising:

i) assaying at least one urine sample from the subject for the amounts of hepcidin-20 and hepcidin-25, and

ii) characterizing the subject'"'"'s risk of having a kidney flare episode within about four months based upon the amounts of hepcidin-20 and hepcidin-25 measured in the at least one urine sample,

wherein the subject is characterized as being at risk of having a kidney flare episode within about four months when there is an increase in hepcidin-20 and a decrease in hepcidin-25 in the at least one urine sample, as compared to predetermined threshold levels.

2. The method of claim 1, wherein the predetermined threshold levels comprise levels of hepcidin-20 and hepcidin-25 measured in at least one additional urine sample taken from the subject at a point in time prior to the assaying step i).

3. The method of claim 1, wherein the method further includes assaying at least one additional urine sample taken from the subject taken at a point in time prior to the assaying of the at least one urine sample in step i).

4. The method of claim 1, wherein the method further includes assaying at least one additional urine sample taken from the subject taken at a point in time after the assaying of the at least one urine sample in step i).

5. A diagnostic method, comprising:

determining the concentrations of hepcidin-20 and hepcidin-25 in a urine sample from a subject suffering from systemic lupus erythematosus,

and diagnosing the subject as being likely to suffer a kidney flare episode within about four months when the hepcidin-20 concentration in the urine sample is increased relative to a threshold hepcidin-20 concentration and the hepcidin-25 concentration in the urine sample is decreased relative to a threshold hepcidin-25 concentration;

wherein a lack of an increase in hepcidin-20 in the sample relative to the threshold hepcidin-20 concentration and a lack of a decrease in hepcidin-25 concentration relative to the threshold hepcidin-25 concentration indicates that a kidney flare episode is not likely to occur in the subject within about four months.

6. The method of claim 5, wherein the increase in hepcidin-20 is present at about four months prior to presentation of symptoms of the kidney flare episode.

7. The method of claim 5, wherein the decrease in hepcidin-25 is present at about two months prior to presentation of symptoms of the kidney flare episode.