Methods and compositions for diagnosis and prognosis of renal injury and renal failure
Inventors
Anderberg, Joseph • Gray, Jeff • McPherson, Paul • Nakamura, Kevin • Kampf, James Patrick
Assignees
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Publication Number
US-12123882-B2
Publication Date
2024-10-22
Expiration Date
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 a plurality of assays, one or more of which is configured to detect a kidney injury marker selected from the group consisting of Hyaluronic acid, Immunoglobulin A, Immunoglobulin G1, Immunoglobulin G2, Insulin-like growth factor-binding protein 7, Alpha-1 antitrypsin, Serum amyloid P component, Metalloproteinase inhibitor 2, Hepatocyte growth factor, Intercellular adhesion molecule 1, Beta-2-glycoprotein 1, Interleukin-1 beta, Neutrophil Elastase, Tumor necrosis factor receptor superfamily member HB, Interleukin-11, Cathepsin D, C-C motif chemokine 24, C-X-C motif chemokine 6, C-C motif chemokine 13, C-X-C motif chemokines-1, -2, and -3, Matrilysin, Interleukin-2 receptor alpha chain, Insulin-like growth factor-binding protein 3, and Macrophage colony-stimulating factor 1 as diagnostic and prognostic biomarkers in renal injuries.
Core Innovation
The invention relates to kidney injury risk evaluation and management using kidney injury markers measured in one or more body fluid samples obtained from a subject. An assay result measuring levels of kidney injury markers is correlated to an increased risk of experiencing a detrimental outcome related to a renal injury when the assay result is above a predetermined threshold, and the assay result combines the levels of the kidney injury markers into a single composite result.
In particular, the kidney injury markers include Insulin-like growth factor-binding protein 7 (IGFB7) and Metalloproteinase inhibitor 2 (TIMP2), and the composite result is produced by combining these marker levels into one single composite result. The description includes risk stratification, diagnosis, prognosis, and staging-related renal injury classification such as prerenal, intrinsic, and postrenal categories.
The method further includes treating the subject having an increased risk of a detrimental outcome related to renal injury with a compatible treatment. The compatible treatment comprises one or more of initiating renal replacement therapy, withdrawing delivery of compounds known to be damaging to the kidney, delaying procedures known to be damaging to the kidney, and modifying diuretic administration.
Claims Coverage
The provided information includes one independent claim. It includes two inventive features tied to correlating a composite assay result of IGFB7 and TIMP2 with increased risk when above a predetermined threshold, and treating the subject with a compatible renal-management intervention set.
Correlating a composite IGFB7/TIMP2 assay result to renal-injury risk above a predetermined threshold
Correlating an assay result measuring levels of kidney injury markers in one or more body fluid samples obtained from the subject to an increased risk of experiencing a detrimental outcome related to a renal injury when the assay result is above a predetermined threshold, wherein the kidney injury markers comprise Insulin-like growth factor-binding protein 7 (IGFB7) and Metalloproteinase inhibitor 2 (TIMP2) and the assay result combines the levels of the kidney injury markers into a single composite result.
Treating increased-risk subjects with a compatible renal-management intervention set
Treating the subject having an increased risk of experiencing a detrimental outcome related to a renal injury with a compatible treatment, wherein the compatible treatment comprises one or more of initiating renal replacement therapy, withdrawing delivery of compounds that are known to be damaging to the kidney, delaying procedures that are known to be damaging to the kidney and modifying diuretic administration.
Across the provided independent claim, the main inventive contribution centers on using IGFB7 and TIMP2 combined into a single composite assay result correlated with increased risk when above a predetermined threshold, followed by treatment using a compatible renal-management intervention set that can include renal replacement therapy initiation and modifications to kidney-damaging care elements.
Stated Advantages
Enables risk correlation of a detrimental outcome related to renal injury when a composite assay result is above a predetermined threshold.
Documented Applications
Risk stratification for acute kidney injury (AKI) and prediction of AKI-related death within 7/14/28 days using multi-marker panel assay results.
Selecting a compatible treatment for a subject having an increased risk of a detrimental outcome related to renal injury based on a composite assay result.
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