Glomerular Filtration Rate Test

肾小球滤过率测试

• 批准号: 7552192
• 负责人: CHRISTOPHER P REINHARDT
• 金额: $ 1.81万
• 依托单位: BIOPAL, INC
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-15 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7552192
• 关键词: Adult; Affect; Affinity; Affinity Chromatography; American; Animal Experimentation; Antibodies; Antibody Formation; Biochemical; Biological Assay; Biological Markers; Blood; Carrier Proteins; Chronic Kidney Failure; Class; Clinical; Clinical Practice Guideline; Clinical Research; Condition; Creatinine; Data; Development; Diagnosis; Diagnostic; Diagnostic Procedure; Diagnostic tests; Diet Modification; Dietary Intervention; Disease; Early Diagnosis; Effective Renal Plasma Flow; End stage renal failure; Enzyme-Linked Immunosorbent Assay; Epidemic; Equation; Filtration; Foundations; Funding; Gadolinium DTPA; Gadopentetate Dimeglumine; Glomerular Filtration Rate; Goals; Gold; Haptens; Health Care Costs; Human; Imaging Techniques; Immune Sera; Immune response; Immunoassay; Injection of therapeutic agent; Inulin; Kidney; Kidney Diseases; Kinetics; Legal patent; Magnetic Resonance Imaging; Measurement; Measures; Medical; Metabolic Clearance Rate; Methods; Molecular Weight; Monitor; Morbidity - disease rate; Numbers; Organ; Oryctolagus cuniculus; Outcome; Patients; Performance; Pharmacologic Substance; Phase; Population; Principal Investigator; Procedures; Process; Production; Publishing; Radioactive; Range; Reagent; Renal clearance function; Renal function; Research; Research Personnel; Risk; Serum; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Staging; Standards of Weights and Measures; System; Techniques; Technology; Testing; Time; United States; United States Food and Drug Administration; Urine; Work; abstracting; base; clinical application; cost; cross reactivity; design; healthy volunteer; immunogenic; improved; in vivo; interest; monoclonal antibody production; mortality; novel; polyclonal antibody; post gamma-globulins; programs; response; size

ABSTRACT Kidney disease in the United States has been described as an epidemic. More than 20 million patients have chronic kidney disease (CKD) and these numbers are increasing annually. As a result, the number of patients with end-stage renal disease (ESRD) is expected to double between 1999 and 2010. These increases in CKD and ESRD are associated with significant morbidity, mortality and healthcare costs. Early detection and treatment of kidney disease has been shown to improve outcomes, but kidney disease is often under diagnosed resulting in lost opportunities to treat. The importance of early diagnosis and treatment of kidney disease has been extensively reviewed and published as a K/DOQI clinical practice guideline by the National Kidney Foundation. Monitoring changes in glomerular filtration rate (GFR) provides the best means for early detection of kidney disease. The test that is most widely used in the US to screen abnormalities in GFR is serum creatinine. However, estimated GFR values using serum creatinine have limited diagnostic value over methods that directly measured GFR using an ideal filtration marker, such as inulin. This Phase I application seeks support to further develop a novel readout system, based on immunoassay technology, to directly measure GFR. Our proposed test will be accurate, simple-to-use, inexpensive and will be widely assessable. The test will utilize FDA-cleared compounds that are known to be GFR markers. As a result, our proposed GFR test will be able to more quickly enter the marketplace.

摘要 肾脏疾病在美国被描述为一种流行病。20多 2000万患者患有慢性肾脏疾病（CKD），并且这些数字正在增加 每年。因此，患有终末期肾病（ESRD）的患者数量是 预计在1999年至2010年期间将翻一番。CKD和ESRD的这些增加是 与显著的发病率、死亡率和医疗保健成本相关。早期发现和 肾脏疾病的治疗已被证明可以改善结果，但肾脏疾病是 往往诊断不足，导致失去治疗的机会。 肾脏疾病的诊断和治疗已被广泛审查和出版 作为国家肾脏基金会的K/DOQI临床实践指南。监测 肾小球滤过率（GFR）的变化提供了早期检测的最佳手段， 肾病在美国最广泛使用的检查异常的测试， GFR是血清肌酐。然而，使用血清肌酐估计的GFR值 与使用理想的GFR直接测量方法相比， 过滤标记物，例如菊粉。第一阶段申请寻求支持， 开发一种基于免疫分析技术的新型读出系统， 测量GFR。我们提出的测试将是准确的，简单易用，便宜， 可以广泛评估。该测试将使用FDA批准的化合物，这些化合物已知是 GFR标志物。因此，我们提出的GFR测试将能够更快地进入 市场。

项目成果

Functional immunoassay technology (FIT), a new approach for measuring physiological functions: application of FIT to measure glomerular filtration rate (GFR).

功能免疫分析技术（FIT），一种测量生理功能的新方法：应用FIT测量肾小球滤过率（GFR）。

• DOI: 10.1152/ajprenal.90354.2008
• 发表时间: 2008
• 期刊: American journal of physiology. Renal physiology
• 作者: Reinhardt,ChristopherPeter;Germain,MichaelJ;Groman,ErnestV;Mulhern,JeffreyG;Kumar,Rajesh;Vaccaro,DennisE
• 通讯作者: Vaccaro,DennisE