Methods and compositions for evaluation and treatment of renal injury and renal failure based on C-C motif chemokine ligand 14 measurement
Inventors
Kampf, James Patrick • McPherson, Paul • CHALFIN, DONALD
Assignees
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Publication Number
US-12203944-B2
Publication Date
2025-01-21
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 assays that detect C-C motif chemokine 14 as diagnostic and prognostic biomarker assays in renal injuries.
Core Innovation
The invention provides a method for evaluating renal status in a subject diagnosed as having acute kidney injury (AKI), wherein the subject meets RIFLE I or F or KDIGO Stage 2 or 3. The method includes performing an assay configured to detect C-C motif chemokine 14 on a body fluid sample obtained from the subject to provide an assay result indicating a level of C-C motif chemokine 14 in the sample.
The method further includes determining that the subject is likely to respond favorably to diuretic treatment when the level of C-C motif chemokine 14 in the sample is below a predetermined threshold. The subject having the level of C-C motif chemokine 14 below the predetermined threshold is treated with diuretic therapy.
A related approach selects the subject for evaluation based on a measured value of one or more AKI biomarkers that exceeds a threshold indicative of an increased risk of having an AKI that meets the definition RIFLE I or F or KDIGO Stage 2 or 3. The disclosed evaluations support rule-in or rule-out of persistent AKI, including persistent stage 3, and provide guidance for treatment selection linked to low versus high urinary CCL14 concentrations.
Claims Coverage
The independent claims are clm-00001 and clm-00005. Each independent claim includes three core inventive features: assaying C-C motif chemokine 14 in a body fluid sample, using a C-C motif chemokine 14 level below a predetermined threshold to determine likely favorable response to diuretic treatment, and treating with diuretic therapy based on that determination.
Renal status evaluation using C-C motif chemokine 14 assay in RIFLE/KDIGO-defined AKI
A method for evaluating renal status in a subject diagnosed as having acute kidney injury (AKI), wherein the subject meets RIFLE I or F or KDIGO Stage 2 or 3, comprising performing an assay configured to detect C-C motif chemokine 14 on a body fluid sample obtained from the subject to provide an assay result indicating a level of C-C motif chemokine 14 in the sample.
Likelihood to respond favorably to diuretic treatment when C-C motif chemokine 14 is below a threshold
Determining that the subject is likely to respond favorably to diuretic treatment when the level of C-C motif chemokine 14 in the sample is below a predetermined threshold.
Diuretic therapy based on C-C motif chemokine 14 level below threshold
Treating the subject having the level of C-C motif chemokine 14 below the predetermined threshold with diuretic therapy.
Subject selection based on AKI biomarkers exceeding an AKI-risk threshold
Selecting the subject for evaluation based on a measured value of one or more AKI biomarkers that exceeds a threshold indicative of an increased risk of having an acute kidney injury that meets the definition RIFLE I or F or KDIGO Stage 2 or 3.
The inventive coverage centers on assaying C-C motif chemokine 14 in a body fluid sample, using a predetermined threshold on the C-C motif chemokine 14 level to determine likely favorable response to diuretic treatment, and treating with diuretic therapy when the C-C motif chemokine 14 level is below the predetermined threshold. Claim clm-00005 further adds subject selection based on one or more AKI biomarkers exceeding a threshold indicative of increased risk.
Stated Advantages
The disclosed evaluations support rule-in or rule-out of persistent AKI, including persistent stage 3.
The disclosed evaluations provide guidance for treatment selection linked to low versus high urinary CCL14 concentrations, including conservative management versus initiating renal replacement therapy (RRT) as described in the partial content summary.
Documented Applications
Evaluation of renal status in suspected or diagnosed AKI, including diagnosis and prognosis, using C-C motif chemokine 14 measurement in body fluids.
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