BIOMARKER FOR EARLY DETECTION OF CHRONIC KIDNEY DISEASE

用于早期检测慢性肾脏病的生物标志物

• 批准号: 8400086
• 负责人: STEPHEN L CARRITHERS
• 金额: $ 95.55万
• 依托单位: SEQUELA
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-20 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8400086
• 关键词: Affect; Age; Albumins; American; Antibodies; Archives; Biological Assay; Biological Markers; Blood Circulation; Cardiovascular Diseases; Characteristics; Chronic Kidney Failure; Clinical; Clinical Trials; Complement; Creatinine; Detection; Development; Diabetes Mellitus; Diagnosis; Diagnostic tests; Disease; Early Diagnosis; Early identification; Early treatment; Enzyme-Linked Immunosorbent Assay; Ethnic Origin; Event; Filtration; Functional disorder; Gender; Glomerular Filtration Rate; Goals; Gold; Health; Hemodialysis; Homeostasis; Hypertension; Impairment; Individual; Kidney; Kidney Diseases; Laboratories; Linear Models; Measures; Medical; Methods; Microalbuminuria; Monitor; National Health and Nutrition Examination Survey; Patients; Performance; Pharmaceutical Preparations; Phase; Physicians; Play; Population; Prevalence; Race; Reagent; Renal function; Risk; Role; Sampling; Serum; Sodium Chloride; Specificity; Staging; Testing; United States; United States National Institutes of Health; Urine; Variant; Water; base; cardiovascular risk factor; case control; commercialization; cost effective; economic impact; follow-up; high risk; insight; novel; phase 1 study; post gamma-globulins; prevent; prohormone; prototype; prouroguanylin; research and development; research clinical testing; scale up

DESCRIPTION (provided by applicant): There are an estimated 26 million Americans with early chronic kidney disease (CKD). Early diagnosis and treatment are the only cost-effective means to reverse this growing problem. NIH recognizes the challenge to diagnose CKD early during its initiation and development phases in order to prevent further renal damage, reduce cardiovascular risk, and minimize the economic impact of CKD. Current methods and biomarkers that are used to assess CKD are effective once the disease is well established but are not reliable for the detection of early disease. Further, many patients initially determined to have a mild decline in kidney function by the current methods may actually be misclassified and possibly under-diagnosed, resulting in a patient having undiagnosed moderate to severe kidney damage. We will produce a new ELISA for CKD to be employed as a diagnostic test based upon the use of a novel biomarker that reflects early events in the pathophysiology of kidney disease. Detection of this biomarker for CKD will give laboratory results and clinical insight that are complementary to creatinine-based glomerular filtration rate (GFR) estimates as well as tests for urine albumin. This should result is a more reliable and earlier identification of CKD. n addition, our CKD-Assay would give physicians the ability to evaluate patients that have been recently diagnosed with hypertension or diabetes. In Phase I, we evaluated the feasibility and proof-of principal of this test and found that the prototype assay in both populations was highly sensitive and specific. In Phase II, we will look for the influence of comorbid conditions and medications on assay performance, compare our results to the gold standard assay of GFR, and follow up patients over at least 3 years to evaluate the ability of this biomarker to follow progression of CKD. Lastly, we will evaluate whether patient characteristics such as age, gender, BMI, ethnicity, and other factors impact on assay performance. We request Phase II support so that we can evaluate the prototype assay and further test its feasibility to help identiy at-risk patients for early kidney disease and monitor therapy with the ultimate goal of obtaining FDA approval and reducing the societal impact of under-diagnosed CKD. PUBLIC HEALTH RELEVANCE: Chronic Kidney Disease affects nearly 26 million people in the United States, which places them at higher risk of cardiovascular disease and hemodialysis. We will develop an assay for the identification of people with advanced kidney disease that are under-diagnosed by current methods and to aid physicians in earlier treatment and better assessment of chronic kidney disease.

描述（由申请人提供）：估计有2600万美国人患有早期慢性肾脏疾病（CKD）。早期诊断和治疗是扭转这一日益严重的问题的唯一经济有效的手段。美国国立卫生研究院认识到，在CKD的发病和发展阶段早期诊断CKD是一项挑战，以防止进一步的肾脏损害，降低心血管风险，并最大限度地减少CKD的经济影响。目前用于评估CKD的方法和生物标志物在疾病确定后是有效的，但对于早期疾病的检测并不可靠。此外，许多患者最初决定