Advance Early Detection of Lupus Nephritis with ClearGold
使用 ClearGold 推进狼疮性肾炎的早期检测
基本信息
- 批准号:9909626
- 负责人:
- 金额:$ 28.84万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2019
- 资助国家:美国
- 起止时间:2019-09-19 至 2021-08-31
- 项目状态:已结题
- 来源:
- 关键词:AddressAffectAmericanAutoimmune DiseasesBiological MarkersBladderChemical EngineeringChemistryClinicalClinical ResearchClinical TrialsDetectionDiagnostic radiologic examinationDiseaseDisease ProgressionEarly DiagnosisEarly InterventionEarly treatmentFinancial HardshipFoundationsGlutathioneGoalsGoldHourImageIndividualInjuryIntravenousInvestigationKidneyKidney FailureKidney TransplantationLeadLeftLupusLupus NephritisMethodsMonitorMonkeysMusNamesNanotechnologyNatureNo-Observed-Adverse-Effect LevelPatientsPhaseProteinsProteinuriaRenal clearance functionRenal functionResearchRiskSolidStagingSurfaceSystemic Lupus ErythematosusTechnologyTestingTimeTranslatingUrinebasebiomaterial compatibilityclinical translationdesigngood laboratory practicein vivoindividual patientinjuredkidney dysfunctionmouse modelnanoGoldnewspre-clinical researchpreclinical toxicitypreventrenal damagescreeningsuccessyoung woman
项目摘要
Summary
Systemic lupus erythematosus (SLE) or lupus is an autoimmune disease that impacts more
than 5 million people worldwide, including 1.5 million Americans. Nearly 60% of these patients
will develop lupus nephritis, which can cause kidney failure. As a result, its financial burden to
individual patient can reach $70,000/year, much higher than many other diseases because of
kidney transplantation. Although early treatment of lupus nephritis can significantly slow down or
even prevent the disease progression to kidney failure, proteinuria, our current gold standard for
screening lupus patients, is not sensitive and accurate enough for early detection of lupus nephritis.
While new biomarkers or exogenous renal function markers are being developed or tested in
clinical trials for early diagnosis of lupus nephritis, their sensitivity and accuracy are comparable
to those of proteinuria. As a result, even today, proteinuria remains the gold standard and there are
strong unmet needs for early detection and accurate monitoring of kidney damages in the lupus
patients. To address this unmet need, ClearNano Inc. is developing a test agent, named
“ClearGold” that can be used to detect lupus nephritis much earlier and more accurately than
proteinuria. In this application, we aim to address two key questions: (1) How accurate this method
is in detection of lupus nephritis; (2) How early this method can identify lupus nephritis in
comparison with proteinuria in the mouse model. The success will validate the competitive
advantages of ClearGold over proteinuria in the early detection of kidney damages in the lupus
mouse model, which will lay down a solid foundation for clinical translation of “ClearGold”.
Through these studies, we believe that a long-standing challenge in the early detection of kidney
damages in the lupus nephritis can be eventually addressed with our “ClearGold” test agent, which
represents a $1.6 Billion market opportunity.
总结
系统性红斑狼疮(SLE)或狼疮是一种自身免疫性疾病,
全世界有500多万人,其中包括150万美国人。近60%的患者
会发展成狼疮性肾炎,导致肾衰竭。因此,其财政负担,
个别病人每年可达7万美元,比许多其他疾病高得多,
肾移植狼疮性肾炎的早期治疗可以显著减缓或
甚至阻止疾病发展到肾衰竭,蛋白尿,我们目前的黄金标准,
狼疮性肾炎的早期诊断有哪些?
虽然新的生物标志物或外源性肾功能标志物正在开发或测试中,
狼疮性肾炎早期诊断的临床试验,其敏感性和准确性是可比的
与蛋白尿有关。因此,即使在今天,蛋白尿仍然是黄金标准,
对狼疮肾损害的早期检测和准确监测的强烈需求尚未得到满足
患者为了解决这一未满足的需求,ClearNano Inc.正在开发一种测试代理,
“ClearGold”可以用来检测狼疮肾炎更早,更准确地比
蛋白尿。在本申请中,我们旨在解决两个关键问题:(1)该方法的准确性如何
狼疮性肾炎的早期诊断方法有哪些?
与小鼠模型中的蛋白尿比较。成功将验证竞争力
ClearGold在狼疮肾损害早期检测中优于蛋白尿
小鼠模型,为“ClearGold”的临床转化奠定了坚实的基础。
通过这些研究,我们认为,长期以来在肾脏疾病的早期检测方面的挑战,
狼疮性肾炎的损害最终可以用我们的“ClearGold”测试剂来解决,
这意味着16亿美元的市场机会。
项目成果
期刊论文数量(0)
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专利数量(0)
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Mengxiao Yu其他文献
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{{ truncateString('Mengxiao Yu', 18)}}的其他基金
Advancing Fluorescence Imaging-guided Partial Nephrectomy with ClearICG
利用 ClearICG 推进荧光成像引导的部分肾切除术
- 批准号:
10379857 - 财政年份:2021
- 资助金额:
$ 28.84万 - 项目类别:
Advancing Fluorescence Imaging-guided Partial Nephrectomy with ClearICG
利用 ClearICG 推进荧光成像引导的部分肾切除术
- 批准号:
10895093 - 财政年份:2021
- 资助金额:
$ 28.84万 - 项目类别:
Unravel Nanoparticle Transport and Interactions in Renal Proximal Tubules
解开纳米颗粒在肾近端小管中的运输和相互作用
- 批准号:
10364680 - 财政年份:2020
- 资助金额:
$ 28.84万 - 项目类别:
Unravel Nanoparticle Transport and Interactions in Renal Proximal Tubules
解开纳米颗粒在肾近端小管中的运输和相互作用
- 批准号:
10597617 - 财政年份:2020
- 资助金额:
$ 28.84万 - 项目类别:
STTR Phase II: Advance Early Detection of Lupus Nephritis with ClearGold
STTR II 期:利用 ClearGold 推进狼疮性肾炎的早期检测
- 批准号:
10494086 - 财政年份:2019
- 资助金额:
$ 28.84万 - 项目类别:
STTR Phase II: Advance Early Detection of Lupus Nephritis with ClearGold
STTR II 期:利用 ClearGold 推进狼疮性肾炎的早期检测
- 批准号:
10258130 - 财政年份:2019
- 资助金额:
$ 28.84万 - 项目类别:
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