US 12,449,426 B2
Method of screening for a chronic kidney disease or glomerulopathy method of monitoring a response to treatment of a chronic kidney disease or glomerulopathy in a subject and a method of treatment of a chronic kidney disease or glomerulopathy
Krzysztof Mucha, Warsaw (PL); Radoslaw Zagozdzon, Truskaw (PL); Bartosz Foroncewicz, Warsaw (PL); Leszek Paczek, Warsaw (PL); Barbara Moszczuk, Warsaw (PL); Natalia Krata, Rzeszow (PL); Dominik Cysewski, Warsaw (PL); Dominik Domanski, Warsaw (PL); Michal Dadlez, Warsaw (PL); and Michal Burdukiewicz, Wroclaw (PL)
Assigned to WARSZAWSKI UNIWERSYTET MEDYCZNY, Warsaw (PL); and INSTYTUT BIOCHEMII I BIOFIZYKI PAN, Warsaw (PL)
Appl. No. 17/906,922
Filed by WARSZAWSKI UNIWERSYTET MEDYCZNY, Warsaw (PL); and INSTYTUT BIOCHEMII I BIOFIZYKI PAN, Warsaw (PL)
PCT Filed Nov. 10, 2020, PCT No. PCT/IB2020/060568
§ 371(c)(1), (2) Date Sep. 21, 2022,
PCT Pub. No. WO2021/152370, PCT Pub. Date Aug. 5, 2021.
Claims priority of application No. 432778 (PL), filed on Jan. 31, 2020.
Prior Publication US 2023/0137242 A1, May 4, 2023
Int. Cl. G01N 33/68 (2006.01)
CPC G01N 33/6893 (2013.01) [G01N 2333/4728 (2013.01); G01N 2333/765 (2013.01); G01N 2333/79 (2013.01); G01N 2333/8125 (2013.01); G01N 2800/347 (2013.01)] 11 Claims
OG exemplary drawing
 
1. 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 (serpina1), 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,
wherein the probability of the subject having or being at a risk of chronic kidney disease or glomerulopathy is assigned in step (b) using the following formula:

OG Complex Work Unit Math
wherein E=17.204550857965−5.75799550569336*10−10*x1−9.37976121221068* 10−9*x2+1.32966288022553*10−8*x3+2.5638225555611*10−8*x4+4.03113433888467*10−7*x5, wherein x1 is the determined level for serum albumin (ALB); x2 is the determined level for alpha-1-antitrypsin (serpina1); x3 is the determined level for alpha-1-acid glycoprotein 1 (ORM1); x4 is the determined level for serotransferrin (TF); and x5 is the determined level for Trefoil factor 1 (TFF1).