Biomarker for Early Detection of Chronic Kidney Disease

早期检测慢性肾脏病的生物标志物

• 批准号: 8146162
• 负责人: STEPHEN L CARRITHERS
• 金额: $ 27.51万
• 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 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8146162
• 关键词: Affect; Age; Albumins; American; Antihypertensive Agents; Award; Biochemical Markers; Biological; Biological Assay; Biological Markers; Blood Circulation; Cardiovascular Diseases; Cardiovascular system; Centers for Disease Control and Prevention (U.S.); Cessation of life; Characteristics; Chronic Kidney Failure; Clinical; Clinical Trials; Collaborations; Collection; Complement; Confusion; Creatinine; Data; Detection; Development; Diabetes Mellitus; Diagnosis; Diagnostic; Diagnostic tests; Dialysis procedure; Diet; Digestive System Disorders; Disease; Disease Outcome; Early Diagnosis; Early treatment; Effectiveness; End stage renal failure; Endocrinology; Enzyme-Linked Immunosorbent Assay; Erythrocytes; Essential Hypertension; Ethnic Origin; Evaluation; Exclusion Criteria; Excretory function; Filtration; Freezing; Functional disorder; Gender; Glomerular Filtration Rate; Goals; Gold; Health; Hematological Disease; Hemodialysis; Homeostasis; Hormonal; Hospitals; Human; Hypertension; Impairment; Indiana; Institutes; Institutional Review Boards; Intervention; Iothalamate; Israel; Kidney; Kidney Diseases; Kidney Failure; Kidney Transplantation; Laboratories; Lead; Letters; Life; Location; Measurement; Measures; Metabolism; Methods; Microalbuminuria; Modeling; Monitor; NIH Program Announcements; National Heart, Lung, and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases; Nephrology; Nephrons; Parents; Participant; Patients; Performance; Pharmaceutical Preparations; Phase; Physicians; Plasma; Play; Population; Population Control; Prevention; Production; Proteins; Protocols documentation; Public Health; Receiver Operating Characteristics; Recording of previous events; Renal Glycosuria; Renal function; Risk; Risk Factors; Role; Sampling; Series; Serum; Site; Small Business Innovation Research Grant; Sodium; Sodium Chloride; Staging; Technology; Testing; Therapeutic Intervention; Transplant Recipients; Transplantation; Transport Process; Tube; United States; United States National Institutes of Health; Universities; Urine; Urologic Diseases; Validation; Waiting Lists; Water; Weight; Work; base; cardiovascular disorder risk; cardiovascular risk factor; cost; cost effective; diabetic; diabetic patient; economic impact; high risk; improved; inorganic phosphate; insight; medical schools; novel; novel diagnostics; post gamma-globulins; prevent; prohormone; prototype; prouroguanylin; public health relevance; receptor; response; tool

DESCRIPTION (provided by applicant): This proposal is submitted in response to the program announcement PA-09-080, "Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])" and intended to be directed to the NIDDK, with a potential dual assignment to the NHLBI. There are an estimated 14 million Americans with early chronic kidney disease (CKD). Early diagnosis and treatment of CKD are the only cost-effective means to reverse this growing problem. Current methods and biomarkers that are used to assess CKD are effective once the disease is well established, but none, thus far, are reliable for the detection of early renal disease. Existing tests used by physicians today are all essentially markers of kidney filtration function. 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 through program announcements such as PA-09-204 (Development and Validation of Disease Biomarkers) and PA-09-181 (Non-Invasive Methods for Diagnosis and Progression of Diabetes, Kidney, Urological, Hematological and Digestive Diseases). We will produce a new ELISA for CKD based upon the use of a novel biomarker that reflects, in part, the pathophysiology of kidney disease. Detection of this biomarker for CKD will give laboratory results and clinical insight that is complementary to creatinine-based GFR estimates (eGFR) as well as tests for urine albumin. Development of this test should result in a more reliable identification and detection of early CKD patients. In addition, our CKD ELISA would give physicians the ability to evaluate patients that have been recently diagnosed with hypertension or diabetes, the two leading causes of CKD. In turn, this Phase I proposal will evaluate the prototype assay in both populations. We will look for the influence of comorbid conditions and medications on assay performance. Lastly, we will evaluate whether patient characteristics such as age, gender, BMI, ethnicity, and other factors impact on assay performance. The information gained from this test will also lead to a better basic understanding of the biological mechanisms underlying CKD. Sequela requests Phase I support so that we can evaluate a prototype assay and test its feasibility to help identify at-risk patients for early kidney disease and monitor therapy with the ultimate goal of obtaining FDA approval. PUBLIC HEALTH RELEVANCE: Chronic Kidney Disease affects nearly 26 million people in the United States, which places them at higher risk of renal failure and hemodialysis. We will develop an ELISA to aid in the diagnosis of early kidney disease to aid physicians in earlier treatment and better assessment of chronic kidney disease.

描述（由申请人提供）：本提案是为了响应项目公告PA-09-080“NIH、CDC和FDA关于小企业创新研究资助申请的综合征求（母公司SBIR [R43/R44]）”而提交的，旨在针对NIDDK，并可能向NHLBI进行双重分配。据估计，有1400万美国人患有早期慢性肾病（CKD）。CKD的早期诊断和治疗是扭转这一日益严重的问题的唯一具有成本效益的手段。目前用于评估CKD的方法和生物标志物在疾病确立后是有效的，但迄今为止，没有一种方法和生物标志物可用于检测早期肾脏疾病。目前医生使用的现有测试基本上都是肾脏滤过功能的标志物。NIH认识到在CKD的初始和发展阶段早期诊断CKD的挑战，以防止进一步的肾损伤，降低心血管风险，并通过PA-09-204等项目公告将CKD的经济影响降至最低（疾病生物标志物的开发和验证）和PA-09-181（糖尿病、肾脏、泌尿、血液和消化系统疾病的诊断和进展的非侵入性方法）。我们将使用一种新的生物标志物，部分反映肾脏疾病的病理生理学，从而产生一种新的CKD ELISA。检测CKD的这种生物标志物将提供实验室结果和临床见解，与基于肌酐的GFR估计值（eGFR）以及尿白蛋白检测互补。该检测的发展将导致更可靠的早期CKD患者的识别和检测。此外，我们的CKD ELISA将使医生能够评估最近被诊断患有高血压或糖尿病的患者，这是CKD的两个主要原因。反过来，本I期提案将在两个人群中评价原型试验。我们将寻找共病和药物对检测性能的影响。最后，我们将评估患者特征（如年龄、性别、BMI、种族和其他因素）是否会影响检测性能。从该测试中获得的信息也将导致对CKD潜在生物学机制的更好的基本理解。Sequela请求I期支持，以便我们能够评估原型检测并测试其可行性，以帮助识别早期肾脏疾病的高危患者并监测治疗，最终目标是获得FDA批准。 公共卫生相关性：慢性肾病影响着美国近2600万人，这使他们面临肾衰竭和血液透析的更高风险。我们将开发一种ELISA来帮助早期肾脏疾病的诊断，以帮助医生早期治疗和更好地评估慢性肾脏疾病。