Urine and Serum Biomarkers Associated with Diabetic Nephropathy
AssigneeIndustrial Technology Research Institute (ITRI)
InventorsWei-Ya Lin, Mary Ya-Ping Yeh, Tzu-Ling Tseng, Ping-Fu Cheng, Tsai-Wei Hsu, Hung-Yi Li, Yi-Ting Chen, Yuh-Feng Ling, Jin-Shuen Chen, Yen-Peng Li
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Abstract
Use of urine and serum biomarkers in diagnosing diabetic nephropathy, staging diabetic nephropathy, monitoring diabetic nephropathy progress, and assessing efficacy of diabetic nephropathy treatments. These biomarkers include urine precursor alpha-2-HS-glycoprotein, urine alpha-1 antitrypsin, urine alpha-1 acid glycoprotein, urine osteopontin, serum osteopontin, their fragments, and combinations thereof.
Claims19
A method for assessing efficacy of a diabetic nephropathy treatment in a subject, comprising:
- determining in the subject a pre-treatment level of a biomarker selected from the group consisting of
- (i) a first urine protein molecule that is precursor alpha-2-HS-glycoprotein or a fragment thereof having at least ten amino acid residues,
- (ii) a second urine protein molecule that is alpha-1 antitrypsin or a fragment thereof having at least ten amino acid residues,
- (iii) a third urine protein molecule that is a fragment of alpha-1 acid glycoprotein having at least ten amino acid residues, and
- (iv) a serum protein molecule that is osteopontin or a fragment thereof having at least ten amino acid residues;
- determining in the patient a post-treatment level of the biomarker;
- and
- assessing efficacy of the treatment based on a change in the level of the biomarker after the treatment,
- wherein the post-treatment level of the biomarker being the same or lower than the pre-treatment level of the biomarker indicates effectiveness of the treatment.
A method for assessing efficacy of a diabetic nephropathy treatment in a subject, comprising:
- obtaining a first urine sample and optionally, a first serum sample from the patient before the treatment,
- obtaining a second urine sample and optionally, a second serum sample from the subject after the treatment,
- determining in the samples levels of a biomarker composed of at least two protein molecules and, optionally, one or more clinical factors, wherein the at least two protein molecules are selected from the group consisting of five protein molecules:
- (i) a first urine protein molecule that is precursor alpha-2-HS-glycoprotein or a fragment thereof having at least ten amino acid residues,
- (ii) a second urine protein molecule that is alpha-1 antitrypsin or a fragment thereof having at least ten amino acid residues,
- (iii) a third urine protein molecule that is alpha-1 acid glycoprotein or a fragment thereof having at least ten amino acid residues,
- (iv) a serum protein molecule that is osteopontin or a fragment thereof having at least ten amino acid residues, and
- (v) a fourth urine protein molecule that is osteopontin or a fragment thereof having at least ten amino acid residues,
- and the clinical factors are selected from the group consisting of age, gender, HbA1c, albumin creatinine ratio, and glomerular filtration rate;
- calculating a first disease score and a second disease score based on the levels of biomarkers in the first and second samples, respectively;
- and
- assessing efficacy of the treatment in the subject,
- wherein the second disease score being equal to or lower than the first disease score indicates effectiveness of the treatment.
Dependencies are inferred from the claim text.