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NOVEL ASSAY TO DETECT CHRONIC KIDNEY DISEASE

检测慢性肾脏病的新方法

基本信息

批准号：
9319737
负责人：
STEPHEN L CARRITHERS
金额：
$ 93.33万
依托单位：
SEQUELA
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-20 至 2020-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9319737
关键词：
Acute Renal Failure with Renal Papillary Necrosis Adult Affect Agreement Albumins American Biological Assay Biological Markers Blinded Calibration Child Chronic Kidney Failure Clinical Clinical Research Clinical Trials Code Communities Creatinine Cyclic GMP Detection Development Devices Diabetes Mellitus Diagnosis Diagnostic Diagnostic radiologic examination Diagnostic tests Disease Doctor of Philosophy Early Diagnosis Early treatment End stage renal failure Enzyme-Linked Immunosorbent Assay Equation Event Family history of Focus Groups Functional disorder Funding Goals Health Insurance Portability and Accountability Act Hemodialysis Howard Temin Award Hypertension ICD-9 In Vitro Injury Intellectual Property Kidney Kidney Diseases Legal patent Measures Methods Minority Groups Morbidity - disease rate Onset of illness Patients Performance Phase Physicians Polycystic Kidney Diseases Populations at Risk Premature Infant Prevalence Process Publishing Quality Control Records Regulatory Pathway Reproducibility of Results Series Sickle Cell Site Specificity System Testing Time Transact United States United States National Institutes of Health Urine Work base cardiovascular risk factor clinical material cohort commercialization cost cost effective cost efficient disorder risk economic impact high risk high risk population loss of function manufacturing process mortality novel novel marker polyclonal antibody post gamma-globulins pre-clinical prevent programs prototype public health relevance research clinical testing risk minimization screening success validation studies

项目摘要

DESCRIPTION (provided by applicant: There are an estimated 26 million Americans with 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. Currently, two complimentary tests - estimated GFR (eGFR) and urine albumin-to-creatinine ratio (UACR) - are used to identify CKD and are effective once the onset of disease has occurred. 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 critical events in the pathophysiology of kidney disease. Preliminary results suggest that our CKD-ASSAY could replace or compliment both predicate assays. Further, the specificity and reproducibility of the results may reduce or eliminate the need for repeat testing. Aside from increased convenience and reduced time to treatment, this may mean that the cost of screening for CKD may be greatly reduced. Our CKD-ASSAY would give physicians the ability to evaluate patients that have been recently diagnosed with hypertension, diabetes, or a family history of CKD. In Phase I, we evaluated the feasibility and proof-of principal of this test and found that the prototype assay in both at-risk populations was highly sensitive and specific. In Phase II, we confirmed the specificity of our CKD-ASSAY, established concordance with other assays, and looked for other factors that might have impacted on assay performance. We request Phase IIB support so that we can prepare cGMP kits, perform the pivotal clinical evaluations, submit our 510(k) application to the FDA, and prepare for commercial launch.