Predictive renal safety biomarkers and biomarker signatures to monitor kidney function

Abstract

Biomarker signatures were identified which can be used to diagnose or predict kidney or liver toxicity and more specifically renal tubular toxicity as a consequence of disease or drug treatment.

We claim: 
     
         1 . A method for assessing renal toxicity or liver toxicity in an individual following administration of compound suspected of causing renal toxicity or liver toxicity, wherein the renal toxicity or liver toxicity is identified by measurement of a set of biomarkers in a sample from the individual and comparison of the measured biomarker amount with the corresponding amount in a healthy individual, wherein the biomarkers are selected from the group consisting of the biomarkers listed in TABLE 1. 
     
     
         2 . The method of  claim 1 , wherein the assessment of liver toxicity is by measurement of the set of protein biomarkers comprising:
 (a) lipocalin-2 measured in a blood, plasma or serum sample from the individual,   (b) glutathione S-transferase mu 1 (GST-mu) measured in a blood, plasma or serum sample from the individual; and   (c) lipocalin-2 measured in a urine sample from the individual.   
     
     
         3 . The method of  claim 1 , wherein the assessment of renal toxicity is by measurement of the set of protein biomarkers comprising:
 (a) cystatin C measured in a blood, plasma or serum sample from the individual,   (b) Kidney Injury Molecule-1 (Kim-1) measured in a urine sample from the individual; and   (c) lipocalin-2 measured in a urine sample from the individual.   
     
     
         4 . The method of  claim 1 , wherein the assessment of renal toxicity is by measurement of a set of gene transcription biomarkers comprising:.
 (a) Kidney Injury Molecule-1 (Kim-1); and   (c) cysteine-rich protein-61 (CYR6 1).