Methods of Diagnosing Renal Disease

Description: Diabetic kidney disease, also known as diabetic nephropathy, will develop in 25-40% of individuals with Type 1 diabetes mellitus, often leading to early death. The development of diabetic nephropathy generally consists of progression from normoalbuminuria (normal Urinary Albumin Excretion, or UAE) through three successive clinical stages: microalbuminuria (MA), characterized by a small increase in UAE; overt proteinuria, characterized by abundant UAE and the beginnings of renal function loss; and end stage renal disease (ESRD), which requires renal replacement therapy and is coupled with high mortality. The invention is based on the inventors’ discovery that polymorphisms in one particular gene are correlated with decreased risk of the progression of proteinuria to ESRD and decreased risk of coronary artery disease. A total of 221 patients with Type I diabetes and overt proteinuria, 51 of which developed ESRD, were followed for an average of 6 years and genotyped at three sites in the target gene. Among patients lacking polymorphism #1, 27% progressed to ESRD, compared to only 8% for individuals having one copy of this polymorphism. Polymorphism #2 was present in 40% of individuals with normoabluminuria but only 23% of those with proteinuria or ESRD. A third polymorphism was present in 35% of individuals with normoabluminuria but only 23% of those with proteinuria or ESRD. Correlations were also found to the incidence of coronory artery disease. Clinical & Commercial Utility: The invention features methods of evaluating a patient to determine predisposition to renal disease (e.g., end stage renal disease or diabetic nephropathy) by evaluating the specific polymorphisms of the invention, e.g., a single nucleotide polymorphism (SNP), at a specified locus. Such a diagnostic test would be valuable in that it would allow identification of patients at risk for ESRD far earlier than is now possible, perhaps making it feasible to screen a large proportion of individuals with Type 1 diabetes. A U.S. patent application claiming this invention has been filed.

Type of Offer: Licensing

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