Kidney disease prognosis prediction method and system

Abstract

The purpose of the present invention is to provide: a method for predicting the prognosis for kidney disease for a subject on the basis of the amount of D- and L-amino acids, from a blood sample; and an analysis system that determines prognosis predictions. This purpose is achieved by using at least one amino acid to predict the prognosis for kidney disease, said amino acid being selected from the group consisting of D-serine, D-asparagine, D-proline, D-alanine, D-leucine, D-lysine, D-allo-isoleucine, L-glutamic acid, L-alanine, L-tryptophan, and L-asparagine.

1 . - 12 . (canceled) 
     
     
         13 . A method for prognosing kidney function in a subject who has not been subjected to a dialysis, comprising:
 measuring the amount of at least one amino acid selected from the group consisting of D-serine, D-asparagine, D-proline, D-alanine, D-leucine, D-lysine, D-allo-isoleucine, L-glutamic acid, L-alanine, L-tryptophan, L-asparagine and L-aspartic acid in a blood sample of the subject, and   correlating an index value based on the amount of amino acid with a prognosis for the subject;   identifying the subject with the index value based on the measured amount of the at least one amino acid being higher than the cutoff value for the respective amino acid as a subject with a prognosis for the decreased kidney function; and   administering to the subject with the prognosis for the decreased kidney function a treatment selected from the group consisting of dialysis, kidney transplant, lifestyle improvement, dietary counseling, blood pressure management, blood sugar management and lipid management.   
     
     
         14 . The method according to  claim 13 , wherein prognosis is determined according to a predetermined cutoff value for the index value in the correlation step. 
     
     
         15 . The method according to  claim 14 , wherein the cutoff value is predetermined by a Kaplan-Meier curve analysis. 
     
     
         16 . The method according to  claim 14 , wherein the cutoff value is 5.6 μmol/L for D-serine, 0.7 μmol/L for D-asparagine, 4.7 μmol/L for D-proline, 5.2 μmol/L for D-alanine, 0.5 μmol/L for D-leucine, 0.6 μmol/L for D-lysine, 0.1 μmol/L for D-alloisoleucine, 65.0 μmol/L for L-glutamic acid, 460 μmol/L for L-alanine, 42.4 μmol/L for L-tryptophan, 67.2 μmol/L for L-asparagine and 32 μmol/L for L-aspartic acid. 
     
     
         17 . The method according to  claim 13 , further comprising a step for measuring the amount of an isomer corresponding to the amino acid, wherein the index value is the ratio of the amount of the amino acid to the amount of the corresponding isomer. 
     
     
         18 . The method according to  claim 13 , wherein the index value is further adjusted for one or more variables selected from the group consisting of eGFR, urinary protein level, diabetes, age, gender, hemoglobin level, mean blood pressure, history of cardiovascular events and presence or absence of anti-hypertensive drug treatment. 
     
     
         19 . A system for prognosing kidney function in a subject who has not been subjected to a dialysis, comprising a storage unit, an input unit, a data processing unit, and an output unit, and comprising the following step:
 inputting cutoff values of index values based on the amounts of chiral amino acids in the blood and prognosis information for determining said prognosis for kidney function from the input unit and storing in the storage unit,   inputting measured amounts of chiral amino acids in the blood of a subject from the input unit and storing in the storage unit,   calculating index values based on the measured amounts of chiral amino acids stored in the storage unit by the data processing unit and comparing with the cutoff values stored with the index values to determine prognosis information for the subject, and   outputting prognosis information to the output unit; wherein,   the chiral amino acids in the blood are at least one amino acid selected from the group consisting of D-serine, D-asparagine, D-proline, D-alanine, D-leucine, D-lysine, D-alloisoleucine, L-glutamic acid, L-alanine, L-tryptophan, L-asparagine and L-aspartic acid.   
     
     
         20 . The system according to  claim 19 , further containing an analysis/measurement unit, wherein the analysis/measurement unit separates chiral amino acids in the blood from a blood sample of a subject and assays the amounts thereof to determine the measured amounts thereof, and inputs the measured amounts instead of the input unit or via the input unit. 
     
     
         21 . The system according to  claim 19 , wherein the cutoff value is predetermined by a Kaplan-Meier curve analysis. 
     
     
         22 . The system according to  claim 19 , wherein the cutoff value is 5.6 μmol/L for D-serine, 0.7 μmol/L for D-asparagine, 4.7 μmol/L for D-proline, 5.2 μmol/L for D-alanine, 0.5 μmol/L for D-leucine, 0.6 μmol/L for D-lysine, 0.1 μmol/L for D-alloisoleucine, 65.0 μmol/L for L-glutamic acid, 460 μmol/L for L-alanine, 42.4 μmol/L for L-tryptophan, 67.2 μmol/L for L-asparagine and 32 μmol/L for L-aspartic acid. 
     
     
         23 . The system according to  claim 19 , wherein the measured amount of an isomer corresponding to the amino acid is further input from the input unit, and the index value is the ratio of the amount of the amino acid to the amount of the corresponding isomer. 
     
     
         24 . The system according to  claim 19 , wherein the index value is further adjusted for one or more variables selected from the group consisting of eGFR, urinary protein level, diabetes, age, gender, hemoglobin level, mean blood pressure, history of cardiovascular events and presence or absence of anti-hypertensive drug treatment.