Biomarkers associated with nephropathy

Abstract

Use of urine biomarkers for diagnosing nephropathy, monitoring nephropathy progress, and assessing efficacy of a nephropathy treatment. These urine biomarkers include leukocyte-associated Ig-like receptor-2, alpha-1 acid glycoprotein, their fragments, and combinations thereof.

1 . A method for monitoring efficacy of a nephropathy treatment in a subject suffering from nephropathy, comprising:
 determining a level of a biomarker in a urine sample from the subject before the treatment, the biomarker being selected from the group consisting of (i) a first protein molecule that is leukocyte-associated Ig-like receptor-2 or a fragment thereof having at least ten amino acid residues, (ii) a second protein molecule that is a fragment of alpha-1 acid glycoprotein having at least ten amino acid residues, (iii) a combination of the first and second protein molecules, and (iv) a combination of the first protein molecule and alpha-1 acid glycoprotein;   determining a level of the biomarker in a urine sample from the subject after the treatment;   assessing efficacy of the treatment based on a change in the level of the biomarker after the treatment,   
       wherein the treatment is effective if the biomarker level after the treatment remains unchanged or decreases as compared to that before treatment. 
     
     
         2 . The method of  claim 1 , wherein the fragment of leukocyte-associated Ig-like receptor-2 is DFLELLVKGTVPGTEASGFDAP (SEQ ID NO:1) and the fragment of alpha-1 acid glycoprotein is GQEHFAHLLILRDTKTYMLAFDVNDEKNWGLS (SEQ ID NO:2). 
     
     
         3 . The method of  claim 1 , wherein the level of the biomarker is determined by a mass spectrometry assay or an immune assay. 
     
     
         4 . The method of  claim 3 , wherein the mass spectrometry assay is selected from the group consisting of MALDI-MS, LC-MS, and LC-MS/MS. 
     
     
         5 . The method of  claim 3 , wherein the immune assay is selected from the group consisting of ELISA, Westernblot, RIA, FIA and LIA. 
     
     
         6 . The method of  claim 1 , wherein the subject is a human. 
     
     
         7 . The method of  claim 1 , wherein the subject is a laboratory animal. 
     
     
         8 . The method of  claim 1 , wherein the biomarker is the first protein molecule. 
     
     
         9 . The method of  claim 8 , wherein the first protein molecule is leukocyte-associated Ig-like receptor-2. 
     
     
         10 . The method of  claim 8 , wherein the first protein molecule is 
       
         
           
                 
                 
                 
               
                     
                   DFLELLVKGTVPGTEASGFDAP. 
                   (SEQ ID NO: 1) 
                 
             
                
               
            
           
         
       
     
     
         11 . The method of  claim 10 , wherein the subject is free of proteinuria. 
     
     
         12 . The method of  claim 1 , wherein the biomarker is the second protein molecule. 
     
     
         13 . The method of  claim 12 , wherein the second protein molecule is 
       
         
           
                 
                 
               
                   GQEHFAHLLILRDTKTYMLAFDVNDEKNWGLS. 
                   (SEQ ID NO: 2) 
                 
             
                
               
            
           
         
       
     
     
         14 . The method of  claim 13 , wherein the subject is free of proteinuria. 
     
     
         15 . The method of  claim 1 , wherein the biomarker is the combination of the first and second protein molecules or the combination of the first protein molecule and alpha-1 acid glycoprotein. 
     
     
         16 . The method of  claim 15 , wherein the first protein molecule is leukocyte-associated Ig-like receptor-2 or a fragment thereof that is DFLELLVKGTVPGTEASGFDAP (SEQ ID NO:1) and the second protein molecule is GQEHFAHLLILRDTKTYMLAFDVNDEKNWGLS (SEQ ID NO:2).