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-11761967-B2
Publication Date
2023-09-19
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 one or more assays configured to detect a kidney injury marker selected from the group consisting of Thymic stromal lymphopoietin, Vascular endothelial growth factor receptor 1, C—C motif chemokine 1, C—C motif chemokine 17, C—C motif chemokine 21, C—C motif chemokine 27, FLT-3 Ligand, Immunoglobulin G subclass 3, Interleukin-1 receptor type I, Interleukin-20, Interleukin-29, Interleukin-7, Platelet-derived growth factor A/B dimer, Platelet-derived growth factor A/A dimer, and MMP9:TIMP2 complex as diagnostic and prognostic biomarkers in renal injuries.
Core Innovation
The claimed methods detect the matrix metalloproteinase-9:tissue inhibitor of metalloproteinase 2 (MMP9:TIMP2) complex in a body fluid sample to evaluate renal status or detect a marker of acute kidney injury. An assay result above a predetermined threshold correlates with an increased risk of acute kidney injury within seven days. This evaluation directs subject selection and administration of a compatible treatment regimen.
Clinical cohort data indicate that urine and EDTA biomarker levels of the MMP9:TIMP2 complex distinguish acute kidney injury progression from non-progression across sampling times. The complex demonstrates elevated levels and discriminatory performance across injury stages, with the highest quartile associated with increased odds of injury. Because the background section is omitted from the provided content, the specific problem being solved is not explicitly described in patent.
Claims Coverage
The claims include independent claims covering three inventive features directed to complex detection, renal risk evaluation, and treatment selection.
Evaluation of renal status and risk-based treatment
Claim 1 covers performing an assay to detect the MMP9:TIMP2 complex in a body fluid sample, correlating an assay result above a predetermined threshold with increased risk of acute kidney injury within seven days, and administering a compatible treatment regimen. [procedural detail omitted for safety]
Detection of an acute kidney injury marker during clinical evaluation
Claim 14 covers performing an assay to detect the level of the MMP9:TIMP2 complex in a urine, whole blood, plasma, or serum sample obtained from a subject under clinical evaluation for kidney injury.
Treatment selection based on complex threshold level
Claim 20 covers selecting a subject for acute kidney injury treatment based on a body fluid MMP9:TIMP2 complex level above a predetermined threshold indicating increased risk within seven days, followed by administering a compatible treatment regimen. [procedural detail omitted for safety]
The independent claims address detecting the MMP9:TIMP2 complex in body fluids, assessing acute kidney injury risk within seven days, and selecting or administering compatible treatment regimens based on threshold levels.
Stated Advantages
The reported cohort results support measuring the MMP9:TIMP2 complex as an acute kidney injury marker and assessing risk of progression, with discriminatory performance reported for urine and EDTA samples.
Documented Applications
Evaluating renal status and identifying increased risk of acute kidney injury within seven days based on detection of the MMP9:TIMP2 complex in a body fluid sample.
Detecting an acute kidney injury marker in a subject under clinical evaluation for kidney injury.
Selecting and treating a subject having increased risk of acute kidney injury using compatible treatment regimens.
Assessing acute kidney injury progression using measurements of the MMP9:TIMP2 complex in urine or EDTA samples.
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