Methods and compositions for diagnosis and prognosis of renal injury and renal failure

Abstract

The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects suffering from or suspected of having a renal injury. In particular, the invention relates to using assays that detect one or more markers selected from the group consisting of Clusterin, Heart-type fatty acid binding protein, Hepatocyte growth factor, Interferon gamma, Interleukin-12 subunit beta, Interleukin-16, Interleukin-2, 72 kDa type IV collagenase, Matrix metalloproteinase-9, Midkine, and Serum amyloid P-component as diagnostic and prognostic biomarkers in renal injuries.

We claim: 
     
         1 . A method for evaluating renal status in a subject, comprising:
 performing one or more assays configured to detect a kidney injury marker selected from the group consisting of Clusterin, Heart-type fatty acid binding protein, Hepatocyte growth factor, Interferon gamma, Interleukin-12 subunit beta, Interleukin-16, Interleukin-2, 72 kDa type IV collagenase, Matrix metalloproteinase-9, Midkine, and Serum amyloid P-component by introducing the urine sample obtained from the subject into an assay instrument which (i) contacts the urine sample with one or more antibodies which specifically bind for detection the biomarker(s) which are assayed, and (ii) generates one or more assay results indicative of binding of each biomarker which is assayed to a respective antibody to provide one or more assay results;   using the one or more assay results, or one or more values derived therefrom, to assign a probability that a future acute renal injury will occur within 48 hours of the time the urine sample is obtained to the subject, wherein the assignment is made by comparing the assay result or value derived therefrom to a predetermined threshold value selected in a population study to separate the population of individuals in the population study into a first subpopulation which is at an increased probability for acute renal failure within 48 hours relative to a second subpopulation; and   if the one or more assay results, or one or more values derived therefrom, assign the subject into the first subpopulation, treating the subject by one or more of initiating renal replacement therapy, withdrawing delivery of compounds that are known to be damaging to the kidney, delaying or avoiding procedures that are known to be damaging to the kidney, and modifying diuretic administration.