Methods and compositions for diagnosis and prognosis of renal injury and renal failure
Inventors
Anderberg, Joseph • McPherson, Paul • Gray, Jeff • Nakamura, Kevin • Kampf, James Patrick • Kwan, Thomas
Assignees
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Publication Number
US-12099067-B2
Publication Date
2024-09-24
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 one or more of C-C motif chemokine 16, C-C motif chemokine 14, and Tyrosine-protein kinase receptor UFO as diagnostic and prognostic biomarker assays in renal injuries.
Core Innovation
The invention relates to a method for evaluating renal status in a subject by detecting C-C motif chemokine 14 on a body fluid sample obtained from the subject to provide an assay result. The assay result is correlated to whether the subject has a current acute kidney injury (AKI) or an increased likelihood of the subject developing a future AKI.
Based on the evaluation, the subject having the current AKI or the increased likelihood of developing a future AKI is treated with a compatible treatment regimen comprising one or more of initiating renal replacement therapy, modifying diuretic administration, or withdrawing delivery of compounds that are known to be damaging to the kidney. The method links biomarker detection to diagnosis, prognosis, and subsequent treatment.
The disclosed approach also describes renal injury biomarker analysis and staging using renal injury biomarkers, including C-C motif chemokine 16 and Tyrosine-protein kinase receptor UFO in addition to C-C motif chemokine 14. The document further frames renal injury status and trajectory using RIFLE-like criteria, urine output and serum creatinine, and risk stratification for future renal decline, AKI progression, and outcomes.
Claims Coverage
One independent claim is identified. The inventive features include performing an assay for C-C motif chemokine 14 on a body fluid sample, correlating the assay result to current AKI or increased likelihood of future AKI, and treating based on that evaluation using a compatible treatment regimen with specified renal-directed actions. The provided refinements further mention timing windows, renal function criteria, immunoassay detection, and subject selection constraints.
Assay detection of C-C motif chemokine 14 from a body fluid sample
Performing an assay method configured to detect C-C motif chemokine 14 on a body fluid sample obtained from the subject to provide an assay result.
Correlation of assay result to current AKI or increased likelihood of future AKI
Correlating the assay result to the subject having a current acute kidney injury (AKI) or an increased likelihood of the subject developing a future AKI.
Treatment regimen based on current AKI or increased likelihood of future AKI
Treating the subject having the current AKI or the increased likelihood of developing a future AKI with a compatible treatment regimen comprising one or more of initiating renal replacement therapy, modifying diuretic administration, or withdrawing delivery of compounds that are known to be damaging to the kidney.
Restricting evaluation to specified AKI timing window after sampling
The method includes limiting such that AKI occurs within 72 hours after obtaining the body fluid sample.
Using immunoassay detection
The method is performed using an immunoassay.
Subject selection using known risk factors for prerenal, intrinsic renal, or postrenal AKI
Selecting a subject for evaluation based on having known risk factors for prerenal, intrinsic renal, or postrenal acute kidney injury (AKI), including one or more known risk factors.
Renal-function criteria using urine output and serum creatinine thresholds
Limiting based on urine output constraints and/or serum creatinine level and serum creatinine increase from baseline.
Overall, the claims center on biomarker-based evaluation of renal status using C-C motif chemokine 14, correlating the assay result to AKI status or future risk, and selecting a compatible treatment regimen that includes renal replacement therapy initiation, diuretic modification, and/or withdrawing kidney-damaging compounds.
Stated Advantages
Quantifies the ability to distinguish persistent renal dysfunction (RIFLE I or F) from non-persistent (RIFLE 0/R) using diagnostic performance metrics including AUC, sensitivities and specificities, and odds ratios with confidence intervals.
Documented Applications
ROC-based comparison in ICU patients of a urinary marker between persistent and non-persistent AKI/renal failure cohorts, stratified by persistence onset window, persistence period duration, renal assessment modality, and urine EDTA sample type.
Renal injury diagnosis/prognosis and risk stratification for future renal decline, AKI progression, and outcomes in clinical cohorts including contrast-induced nephropathy, cardiac surgery, and ICU cohorts.
Diagnosis determination of current renal injury stages and monitoring improvement or worsening using biomarker measurement.
Classification of injury etiology using prerenal/intrinsic/postrenal categorization and staging using RIFLE-like criteria.
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