Disclosed are methods for predicting, inhibiting, and treating chronic kidney disease (CKD) in a subject that that is preparing to undergo a liver transplant. The methods may include detecting a protein biomarker in a serum sample from the subject prior to the subject being administered a liver transplant procedure and/or after the subject has been administered the liver transplant procedure. Suitable protein markers for the disclosed methods may include but are not limited to osteopontin (OPN) and/or tissue inhibitor of metalloproteases 1 (TIMP1).

It is an object of the present invention to provide methods and compositions for protection of subjects from acute kidney injury by treating the subject with compounds that modulate the cell cycle. Modulating the cell cycle can comprise inducing G.sub.0/G.sub.1 cell cycle arrest, and/or inducing cell cycle progression. As demonstrated below, even a single administration of a compound which induces G.sub.0/G.sub.1 cell cycle arrest can protect subjects from AKI, and may be used prophylactically in advance of, or as a treatment following, various treatments or conditions that are known to be injurious to the kidney, followed optionally by release of the arrest. Once AKI is established, cell cycle progression can be induced to increase replacement of lost and damaged cells.

The present invention relates to an in vitro method for assessing cholangiocarcinoma in a patient sample, comprising the steps of: a) determining the level of tissue inhibitor of metalloproteinase-1 (TIMP1) in the patient sample, wherein the patient sample is selected from a group consisting of serum, plasma and whole blood sample from an individual, b) comparing the level of TIMP1 determined in step (a) with a reference level of TIMP1, and c) assessing cholangiocarcinoma in the patient sample by comparing the level determined in step (a) to the reference level of TIMP1, wherein an increased level of TIMP1 compared to the reference level of TIMP1 is indicative for cholangiocarcinoma in the patient sample. Further, the present invention relates to an in vitro method for assessing cholangiocarcinoma comprising TIMP1 and MMP2, the use of TIMP1 and optionally MMP2 in the in vitro assessment of CCA, and a kit for performing the said methods.

It is an object of the present invention to provide methods and compositions for protection of subjects from acute kidney injury by treating the subject with compounds that modulate the cell cycle. Modulating the cell cycle can comprise inducing G.sub.0/G.sub.1 cell cycle arrest, and/or inducing cell cycle progression. As demonstrated below, even a single administration of a compound which induces G.sub.0/G.sub.1 cell cycle arrest can protect subjects from AKI, and may be used prophylactically in advance of, or as a treatment following, various treatments or conditions that are known to be injurious to the kidney, followed optionally by release of the arrest. Once AKI is established, cell cycle progression can be induced to increase replacement of lost and damaged cells.

Biomarkers are provided that predict whether a human subject having a renal cell carcinoma is responsive to a combination therapy comprising lenvatinib or a pharmaceutically acceptable salt thereof (e.g., lenvatinib mesylate) and everolimus. The biomarkers, compositions, and methods described herein are useful in selecting appropriate treatment modalities for and treating a subject having, suspected of having, or at risk of developing a renal cell carcinoma.

Provided are methods and related kits for detection of early stage pancreatic ductal adenocarcinoma. Also provided are methods for treating a patient susceptible, or suspected of being susceptible, to pancreatic ductal adenocarcinoma.

Described herein are methods for assessing likelihood of response of subjects to activatable therapeutic agents and compositions, kits, and methods of preparing and using activatable therapeutic agents. Also described herein are methods for assessing likelihood of response of subjects to activatable therapeutic agents. In some cases, the activatable therapeutic agents of the compositions, kits, and methods disclosed herein can comprise a mammalian protein-derived sequence.

The present invention concerns markers of multiple sclerosis, their use, and treatment with IL-17 antagonists, including IL-17 antibodies, of subjects with increased levels of such markers.

The disclosure provides biomarker proteins, a change in the concentration or activity level of which are associated with atypical hemolytic uremic syndrome (aHUS) or clinically meaningful treatment of aHUS with a complement inhibitor. Also provided are compositions and methods for interrogating the concentration and/or activity of one or more of the biomarker proteins in a biological fluid. The compositions and methods are useful for, among other things, evaluating risk for developing aHUS, diagnosing aHUS, determining whether a subject is experiencing the first acute presentation of aHUS, monitoring progression or abatement of aHUS, and/or monitoring response to treatment with a complement inhibitor or optimizing such treatment.

Methods and devices for diagnosing, monitoring, or determining diabetic nephropathy or an associated disorder in a mammal are described. In particular, methods and devices for diagnosing, monitoring, or determining diabetic nephropathy or an associated disorder using measured concentrations of a combination of three or more analytes in a test sample taken from the mammal are described.