Markers for renal disease
Inventors
YERRAMILLI, Mahalakshimi • Atkinson, Michael Randolph • Yerramilli, Murthy V. S. N.
Assignees
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Publication Number
US-12241900-B2
Publication Date
2025-03-04
Expiration Date
Abstract
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.
Core Innovation
The invention relates to renal-disease biomarkers for diagnosing and monitoring kidney disease. The biomarkers include an inosine metabolite and a defined panel of full-length proteins and protein fragments, including apolipoprotein C-I, apolipoprotein C-II, fibrinogen alpha and A-alpha fragments, kininogen, ITIH4, keratin Type I cytoskeletal 10, cystatin A, cystatin B, and variants defined as SEQ ID NOs: 1-59.
The diagnostic use is based on detecting differential levels of the biomarker(s) in renal patient biofluids, including blood, serum, plasma, and urine. The detection includes immunoassays using antibodies directed to specific SEQ ID NO variants and protein quantification using LC/MS metabolomics/protein quantification.
The disclosure provides experimental support using canine renal disease models, including XLHN hereditary nephropathy and dichromate-induced acute renal failure. In these models, differential peptide and protein levels are described as biomarkers, including serum inosine depletion associated with kidney dysfunction/tubular failure markers and disease-progression trends in XLHN dogs.
Claims Coverage
The provided independent claim recites diagnosis and treatment prior to stage 3 of kidney disease in a canine patient, based on detecting differentially expressed canine Cystatin B polypeptides. The inventive features center on differential expression detection of selected Cystatin B polypeptides in a canine patient sample and corresponding treatment with dialysis and/or a diet low in phosphorous and protein.
Differential detection of canine Cystatin B for pre-stage 3 diagnosis
Detecting the amount of at least one canine Cystatin B polypeptide selected from the group consisting of full length canine Cystatin B, SEQ ID NO:32, SEQ ID NO:33, SEQ ID NO:34, SEQ ID NO:35, SEQ ID NO:36, SEQ ID NO:37, and SEQ ID NO:38 in a canine patient sample; diagnosing the canine patient with kidney disease prior to stage 3 where the amount of the at least one Cystatin B polypeptide is differentially expressed as compared to a control.
Treatment of pre-stage 3 kidney disease using dialysis and/or low phosphorous and protein diet
Treating the canine patient with dialysis; a diet low in phosphorous and protein; or dialysis and a diet low in phosphorous and protein.
Across the independent claim, the core claim scope requires diagnosing kidney disease prior to stage 3 by detecting a differentially expressed amount of at least one specified canine Cystatin B polypeptide variant in a canine patient sample, and then treating with dialysis and/or a diet low in phosphorous and protein.
Stated Advantages
Documented Applications
No documented applications found
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