Clinical Trial of the FAST Real-Time GFR System

FAST 实时 GFR 系统的临床试验

• 批准号: 8399220
• 负责人: Daniel Meier
• 金额: $ 104.57万
• 依托单位: PHARMACOPHOTONICS, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-20 至 2014-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8399220
• 关键词: Acute; Acute Renal Failure with Renal Papillary Necrosis; Adopted; Animal Model; Biological Assay; Blood; Blood Plasma Volume; Blood Vessels; Canis familiaris; Caring; Catheters; Chronic Kidney Failure; Clinical; Clinical Protocols; Clinical Trials; Consult; Creatinine; Development; Devices; Diagnosis; Diagnostic; Disease Progression; Dose; Drug Kinetics; Early Diagnosis; End stage renal failure; Equation; Equilibrium; Evaluation; Fiber Optics; Fluorescence; Funding; Glomerular Filtration Rate; Goals; Gold; Hour; Human; Image; Impaired Renal Function; Impairment; Injury; Injury to Kidney; Iohexol; Kidney; Kidney Diseases; Kidney Function Tests; Knowledge; Label; Life; Literature; Measurement; Measures; Methodology; Methods; Modeling; Monitor; Morbidity - disease rate; Onset of illness; Optics; Outcome; Patients; Performance; Peripheral; Pharmaceutical Preparations; Phase; Physiological; Pilot Projects; Radioactivity; Renal function; Reporter; Research; Role; Safety; Serum; Severities; Signal Transduction; Small Business Innovation Research Grant; Stratification; Stream; System; Techniques; Technology; Testing; Therapy Evaluation; Time; Translations; Transplant Recipients; Venous; Visual; base; clinical application; comparative efficacy; detector; healthy volunteer; high risk; human disease; improved; minimally invasive; mortality; new technology; point of care; post gamma-globulins; prototype; rapid detection; rapid technique; ratiometric; response; standard measure; success; urinary

DESCRIPTION (provided by applicant): PharmacoPhotonics (DBA FAST, Inc.) proposes Fast-Track research to determine GFR in its first human Pilot study. The long-term goal of this SBIR project is to test FAST's minimally invasive catheter based fluorescent device in humans and commercialize this device for rapid detection and quantification of glomerular filtration rate (GFR) in patients with acute kidney injury (AKI) and/or chronic kidney disease (CKD). AKI remains a vexing clinical problem resulting in unacceptably high patient mortality, development of CKD and enhanced progression to end stage renal disease. FAST has developed the FAST GFR SystemTM, a minimally invasive technique for direct measurement of GFR. In CKD patients, the estimated GFR (eGFR) method for determining baseline GFR and following disease progression and response to therapy has proved to be a disappointment. Having a rapid point of care ability to measure GFR (mGFR) would greatly improve patient stratification, management and evaluation of therapies. The System is intended as an adjunct to current methods utilized to assess renal function. This System has been successfully tested under physiologic and AKI conditions in dogs, and shows a close correlation with a research gold standard measure of GFR. Based upon this success, FAST proposes to test the FAST GFR SystemTM device in humans (Phase I Specific Aim 1) for determination of GFR and plasma volume, under an FDA- Investigational Device Exemption (IDE) Pilot Human Trial (A). GFR will be determined in eight (8) healthy volunteers in order to evaluate system safety and efficacy as compared to iohexol clearance, establish human dosing and testing parameters, and evaluate the pharmacokinetic profile of the intravenously injected visual fluorescent injectate. Based on the success of Phase I, FAST will then test the FAST GFR SystemTM for determination of GFR and plasma volume, under an FDA-IDE for a Pilot Human Trial (B) in Phase II Specific Aim 1. GFR will be determined in a total of twenty-four (24) subjects with widely varying renal impairment, including AKI, to allow for evaluation of safety and efficacy over the spectrum of GFRs seen in kidney disease. This FAST GFR SystemTM method is of major clinical importance in AKI and CKD patients, especially in high risk patients where intense surveillance is necessary for early diagnosis, stratification by severity, and response to therapy. Furthermore, this new technology for rapid measurement of GFR will for the first time permit early dynamic assessment of kidney function in multiple animal models of human disease; thus expanding scientific knowledge regarding the role of kidney function during early disease onset.

描述（由申请人提供）：PharmacoPhotonics （DBA FAST, Inc.）在其首次人体先导研究中提出快速通道研究以确定GFR。该SBIR项目的长期目标是在人体中测试FAST的微创导管荧光装置，并将该装置商业化，用于快速检测和量化急性肾损伤（AKI）和/或慢性肾脏疾病（CKD）患者的肾小球滤过率（GFR）。AKI仍然是一个令人烦恼的临床问题，导致不可接受的高患者死亡率，CKD的发展和终末期肾脏疾病的加速进展。FAST开发了FAST GFR SystemTM，这是一种直接测量GFR的微创技术。在CKD患者中，用于确定基线GFR和跟踪疾病进展和治疗反应的估计GFR （eGFR）方法已被证明是令人失望的。拥有快速测量GFR （mGFR）的护理点能力将极大地改善患者分层、治疗管理和评估。该系统旨在作为目前用于评估肾功能的方法的辅助手段。该系统已成功地在狗的生理和AKI条件下进行了测试，并与GFR的研究金标准测量密切相关。基于这一成功，FAST提议在FDA-研究器械豁免（IDE）人体试验(A)下对FAST GFR SystemTM设备进行人体测试（I期特异性目标1），以确定GFR和血浆体积。将在8名健康志愿者中测定GFR，以评估与碘hexol清除率相比的系统安全性和有效性，建立人体剂量和测试参数，并评估静脉注射视觉荧光注射液的药代动力学特征。基于I期的成功，FAST将在FDA-IDE的II期特异性目标1的中试人体试验(B)下测试FAST GFR SystemTM，以测定GFR和血浆体积。GFR将在包括AKI在内的24例肾损害患者中进行测定，以便在肾脏疾病中观察到的GFR谱上评估安全性和有效性。这种FAST GFR SystemTM方法在AKI和CKD患者中具有重要的临床意义，特别是在需要加强监测以进行早期诊断、根据严重程度分层和治疗反应的高风险患者中。此外，这种快速测量GFR的新技术将首次允许在多种人类疾病动物模型中对肾功能进行早期动态评估；从而扩大了关于肾脏功能在疾病早期发病中的作用的科学知识。