The present invention relates to a composition using a urine sample for diagnosis of a kidney disease and, more specifically, to a urine test composition and a kit for diagnosis of a kidney disease, each comprising an agent specifically detecting amphiregulin from a urine sample, and a method for diagnosing a kidney disease by using the composition. According to the present invention, not only is there an advantage of being able to conveniently diagnose a kidney disease in a non-invasive manner using a urine sample for a kidney disease to which early diagnosis is important, but also the application of the present invention to a patient diagnosed with chronic kidney disease can advantageously predict the plausibility of progression into end-stage renal disease in advance.

By using a fully phenotyped cohort of kidney transplant recipients (KTRs), inventors have clearly established the clinical conditions that should be considered when using urinary chemokine levels to noninvasively identify patients at risk of acute rejection (AR). They have developed and validated (in two external validation cohorts) a multiparametric model that predicts individual risk of AR with high accuracy. Accordingly, the invention relates to a method for calculating a probability (p) to have a risk of an acute rejection (AR) in a kidney transplant recipient by using the following equation: (I)

[00001]$\begin{array}{cc}p=\frac{1}{\begin{array}{c}1+\exp (-(\mathrm{\beta 0}+\mathrm{\beta 1}x1+\mathrm{\beta 2}x2+\mathrm{\beta 3}x3+\mathrm{\beta 4}x4+\\ \mathrm{\beta 5}x5+\mathrm{\beta 6}x6+\mathrm{\beta 7}x7+\mathrm{\beta 8}x8))\end{array}}.& \left(1\right)\end{array}$

Disclose are methods, compositions and kits for the determination of kidney function that provide an alternative to the standard-of-cure used for eGFR calculations. Described herein are methods for quantitative measurement of ADMA and hydration markers in a urine sample, and process used to transform the input of these methods into a measure of kidney function. The methods allow ADMA and other biomarkers to be detected in urine samples from a subject using a simple and inexpensive assay that can be easily performed noninvasively and only require urine samples for the prediction of kidney function.

The present disclosure provides methods of treating a subject having a kidney disease or preventing a subject from developing a kidney disease, and methods of identifying subjects having an increased risk of developing a kidney disease.

A method for determining in a sample, by mass spectrometry, the amount of one or more analytes selected from the group consisting of N-acetylthreonine, TMAP, phenylacetylglutamine, tryptophan, creatinine, meso-erythritol, arabitol, myo-inositol, N-acetyl serine, N-acetylalanine, 3-methylhistidine, trans-4-hydroxyproline, kynurenine, urea, C-glycosyltryptophan, 3-indoxyl sulfate, pseudouridine, and combinations thereof is described. The method comprises subjecting the sample to an ionization source under conditions suitable to produce one or more ions detectable by mass spectrometry from each of the one or more of the analytes; measuring, by mass spectrometry, the amount of the one or more ions from each of the one or more analytes; and using the measured amount of the one or more ions to determine the amount of each of the one or more analytes in the sample. Also described is a kit comprising one or more isotopically labeled analogues as internal standards for each of the one or more analytes.

Methods of detecting the presence of one copy or 2 copies of a minor allele of one or more single nucleotide polymorphisms selected from the group consisting of SNP A3_117040611, SNP A3_117041908 and SNP A3_117081913 are disclosed. Methods of identifying a feline subject as being at an increased likelihood of developing cat kidney disease are disclosed. Methods of monitoring the health of a feline subject identified as having an increased likelihood of developing CKD are provided. Methods of monitoring the health of a feline subject and response to treatment for renal disease that comprise quantifying at 2PY present are provided. Methods of delaying onset and severity of cat kidney disease in a feline subject identified as having an increased likelihood of developing CKD and methods of treating cats that have CKD are provided.

This invention provides reagents and methods for diagnosing renal disease. Differential levels of inosine metabolite, and proteins: apolipoprotein C-I, apolipoprotein C-II, fibrinogen alpha chain, or fibrinogen A-alpha chain, kininogen, Inter-Alpha Inhibitor H4 (ITIH4), keratin Type I cytoskeletol 10 cystatin A, cystatin B and other polypeptides and fragments thereof provide biomarkers of renal disease and are described herein.

The object of the present invention is a method of diagnosis of a chronic kidney disease (CKD) or glomerulopathy in a subject, comprising the following steps: (a) determination of the level of at least three or four or five protein markers selected from the group consisting of serum albumin (ALB), alpha-1-antitrypsin (serpinal), alpha-1-acid glycoprotein 1 (ORM1), serotransferrin (TF) and trefoil factor 1 (TFF), wherein said markers also comprise the non-full-length fragments thereof, in a urine sample from said subject and (b) assigning a probability of the subject having or being at a risk of chronic kidney disease or glomerulopathy or not having nor being at a risk thereof based on the results of the assay of step (a), wherein this involves estimating a probability of the subject having or being at a risk of chronic kidney disease or glomerulopathy or not having nor being at a risk thereof based on the level of each of the marker levels determined in (a)), the probability being estimated based on the levels of each of the markers as determined in subjects known to suffer from a glomerulopathy or a chronic kidney disease; and determining the probability of the subject, providing the urine sample tested in step (a), having or being at a risk of a glomerulopathy or a chronic kidney disease or not having nor being at a risk thereof as a product of the corresponding probabilities obtained from each marker. A further object of the present invention is a method of monitoring a response to treatment of a chronic kidney disease (CKD) or glomerulopathy in a subject, comprising the following steps: a) measurement of the level, at a first point in time, for three or four or five of the markers selected from a group consisting of serum albumin (ALB), alpha-1-antitrypsin (serpinal), alpha-1-acid glycoprotein 1 (ORM1), serotransferrin (TF) and trefoil factor 1 (TFF), wherein said markers also comprise the non-full-length fragments thereof, in a urine sample from a subject; b) repeating the assay of step (a) at a later point in time after a period wherein the subject was undergoing a treatment; c) assessing a response to said treatment by comparing the results of the assays of steps (a) and (b), wherein lower marker levels after treatment are indicative of a positive response to treatment. A further object of the present invention is a method of treatment of a chronic kidney disease (CKD) or glomerulopathy in a subject, comprising the following steps: (a) determination of the level of at least three or four or five protein markers selected from the group consisting of serum albumin (ALB), alpha-1-antitrypsin (serpinal), alpha-1-acid glycoprotein 1 (ORM1), serotransferr

Netrin G1 is disclosed as a biomarker of membranous glomerulonephritis (MGN). Netrin G1 antigen-comprising polypeptides and Netrin G1 antibodies can be used in in vitro methods and kits for diagnosis, prognosis and monitoring of MGN of patients with circulating Netrin G1 autoantibodies.

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.