Methods of diagnosing and predicting renal decline
OwnerAndrzej Krolewskiinventor
Life of this patent
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Abstract
The present disclosure provides methods for identifying a human subject at risk of developing progressive renal decline by examining a level(s) of a protective protein(s) in a sample from the subject. Level(s) of protein(s) identified in the disclosure are associated with protection against progressive renal failure and end-stage kidney disease (ESKD). Examples of such protective proteins include FGF20, ANGPT1, and TNFSF12.
Claims33
A method of identifying a human subject at risk of developing progressive renal decline, said method comprising
- detecting a level of at least one protective protein in a sample(s) from a subject in need thereof, wherein the protective protein is selected from the group consisting of fibroblast growth factor 20 (FGF20), angiopoietin-2 (ANGPT1), and tumor necrosis factor ligand superfamily member 12 (TNFSF12),
- comparing the level of the protective protein with a reference level of the protective protein, wherein the reference level is a level of the protective protein in a non-progressor human subject,
- wherein a lower level of the protective protein in comparison to the non-progressor reference level indicates that the human subject is at risk of developing progressive renal decline, or
- wherein an equivalent or higher level of the protective protein in comparison to the reference level indicates that the human subject is not at risk of developing progressive renal decline.
A method of identifying a human subject at risk of developing progressive renal decline, said method comprising
- detecting a level of at least one protective protein in a sample(s) from a subject in need thereof, wherein the protective protein is selected from the group consisting of
- a protective protein from a first group of protective proteins selected from the group consisting of Testican-2, secreted protein acidic and rich in cysteine (SPARC), C-C motif chemokine 5 (CCL5), amyloid beta A4 protein (APP), platelet factor-4 (PF4) and ANGPT1,
- a protective protein from a second group of protective proteins selected from the group consisting of DNAJC19 and TNFSF12, and FGF20,
- comparing the level of the protective protein with a reference level of the protective protein, wherein the reference level is a level of the protective protein in a non-progressor human subject,
- wherein a lower level of the protective protein in comparison to the reference level indicates that the human subject is at risk of developing progressive renal decline, or
- wherein an equivalent or higher level of the protective protein in comparison to the reference level indicates that the human subject is not at risk of developing progressive renal decline.
7-10. (canceled)
12-14. (canceled)
16-17. (canceled)
A protein array for identifying or monitoring progressive renal decline of a human subject, said protein array comprising antibodies or antigen-binding fragments thereof, specific for human FGF20, human TNFSF12, human ANGPT1, human Testican-2, human SPARC, human CCL5, human APP, human PF4, human ANGPT1, human DNAJC19, human TNFSF12, or combinations thereof;
- and/or a plurality of probes for specifically binding a protein biomarker, wherein the protein biomarker is at least one of human FGF20, human TNSF12, human ANGPT1 human Testican-2, human SPARC, human CCL5, human APP, human PF4, and human DNAJC19.
20-22. (canceled)
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A method of treating or preventing renal decline in a human subject, said method comprising
- administering to a subject an effective amount of at least one protective protein and/or at least one agonist of a protective protein.
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29-37. (canceled)
A method of determining the approximate risk of renal decline in a human subject in a defined time period, the method comprising:
- a) obtaining a biological sample from the human subject;
- b) detecting the level of at least one protective protein in the biological sample, wherein the at least one protective protein is selected from the group consisting of FGF20, TNFSF12, ANGPT1, Testican-2, SPARC, CCL5, APP, PF4, and DNAJC19;
- c) combining data on the level of the protective proteins with clinical data features of the human subject (such as eGFR, uACR, Clinical Chemistry laboratory measurements, vital signs, patient demographics);
- and
- d) determining the approximate risk of renal decline (RD) for the human subject as determined using a machine-learned or statistically modelled, prognostic risk-score algorithm (e.g., KidneyIntelX test platform).
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Dependencies are inferred from the claim text.