Chronic Kidney Disease Precision Medicine Project

慢性肾脏病精准医疗项目

• 批准号: 10223908
• 负责人: ROBERT Daniel TOTO
• 金额: $ 30万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10223908
• 关键词: Affect; Atlases; Biological Factors; Biopsy; Blood; Caring; Cessation of life; Characteristics; Chronic Kidney Failure; Clinical; Clinical Data; Clinical Research; Clinical Research Protocols; Clinical Trials; Cohort Studies; Communities; Consent; Coupled; Data; Diabetes Mellitus; Diagnosis; Education; Electronic Health Record; End stage renal failure; Enrollment; Ensure; Ethics; Evaluation; Functional Magnetic Resonance Imaging; Funding; Future; Health; Health Resources; Healthcare Systems; Hospitals; Hypertension; Image; Individual; Informatics; Information Technology; Informed Consent; Infrastructure; Intervention; Kidney; Kidney Failure; Knowledge; Longitudinal cohort study; Medical Economics; Methodology; Modeling; Multicenter Studies; National Institute of Diabetes and Digestive and Kidney Diseases; Outcome; Outcomes Research; Participant; Patient Care; Patient Recruitments; Patient-Focused Outcomes; Patients; Phase; Phenotype; Population; Precision Medicine Initiative; Probability; Process; Process Assessment; Prospective Studies; Prospective cohort study; Protocols documentation; Public Health; Research; Research Personnel; Resources; Safety; Sampling; Site; Socioeconomic Factors; System; Texas; Time; Tissues; United States National Institutes of Health; Urine; Work; base; clinical phenotype; clinical practice; cohort; collaboratory; disorder subtype; experience; high risk; improved; informatics tool; innovation; kidney biopsy; novel; patient oriented; patient population; personalized care; phenotypic data; pragmatic trial; precision medicine; primary outcome; programs; radiologist; recruit; single photon emission computed tomography; socioeconomics; sound; systems research; therapeutic target; tool; translational medicine

The current understanding of the pathophysiologic and socio-economic processes that initiate CKD and the paths by which they progress to ESRD are poorly understood, resulting in limited treatments. There is a compelling unmet need for prospective studies to accurately phenotype patients with CKD using a combination of kidney biopsy, clinical, biologic, and socioeconomic factors to develop individualized care to improve patient outcomes. We are currently conducting the largest pragmatic trial in CKD sponsored by the NIH Collaboratory for Health Care Systems (HCS) Research using novel electronic health records (EHR) - based informatics to identify and facilitate care for patients with CKD, diabetes and hypertension, including large numbers of underserved patients. We now propose a prospective cohort study (Precise-CKD) in patients with CKD as part of the Kidney Precision Medicine Program (KPMP). We hypothesize that our large and diverse HCS will successfully obtain kidney biopsies, biosamples and clinical data from patients with CKD and that with that approach we will identify disease subgroups and contribute to the creation of a kidney tissue atlas as part of the KPMP. In the Planning Phase UG 3 of this proposal we will use our existing, fully functioning, novel information technology tools leveraging our electronic health record systems to identify, recruit, enroll and obtain clinical data, biosamples and kidney biopsies from patients with CKD-Diabetes and CKD-Hypertension from 3 large HCS. We will engage community and patient stakeholders to develop ethically-sound, patient-centered processes to engage patients with CKD in the study and obtain consent for kidney biopsies. We will work closely with KPMP to develop common study protocols and following maximum safety precautions we will obtain high quality kidney biopsies from 40 patients. In the Implementation Phase UH3 we will increase recruitment and obtain kidney biopsies, biosamples and clinical data from an additional 400 patients with CKD-diabetes and CKD-HTN adding another large HCS. We will also expand the cohort of CKD patients likely to yield actionable results based on high risk for progression (eGFR decline >30% over 2 years), novel imaging findings (fMRI or SPECT from UTSW) or results from other KPMP investigators from UG3 suggesting probability of identifying therapeutic targets. The long-standing successful track record of our group in recruiting patients into clinical trials of CKD, the large, and diverse patient populations available for recruitment at our site, the fully functioning infrastructure for identifying and recruiting patients from multiple healthcare systems with novel informatics tools, and the ethically rigorous approach to consenting for kidney biopsy coupled with the rigorously safe methodology will facilitate our efforts to contribute to the KPMP.

目前对引发CKD的病理生理学和社会经济学过程的理解， 他们进展为ESRD的途径知之甚少，导致治疗有限。有一个 迫切需要进行前瞻性研究，以使用联合治疗对CKD患者进行准确的表型分析， 肾活检，临床，生物学和社会经济因素，以发展个性化护理，以改善患者 结果。我们目前正在进行由NIH合作实验室赞助的最大规模的CKD实用性试验 用于医疗保健系统（HCS）研究，使用基于信息学的新型电子健康记录（EHR）， 确定并促进对CKD、糖尿病和高血压患者的护理，包括大量 缺医少药的病人我们现在提出了一项在CKD患者中进行的前瞻性队列研究（Precise-CKD）， 肾脏精准医学计划（KPMP）我们假设我们庞大而多样的HCS将 成功地获得了CKD患者肾活检、生物样品和临床数据， 方法，我们将确定疾病亚组，并有助于建立一个肾脏组织图谱的一部分， KPMP 在本提案的规划阶段UG 3中，我们将使用我们现有的、功能齐全的新信息 技术工具，利用我们的电子健康记录系统，以识别，招募，登记和获得临床 来自3个大城市的CKD-糖尿病和CKD-高血压患者的数据、生物样本和肾活检 HCS。我们将与社区和患者利益相关者合作，制定符合道德标准的、以患者为中心的 CKD患者参与研究并获得肾活检同意书的流程。我们将密切合作 与KPMP一起制定共同的研究方案，并遵循最大的安全预防措施，我们将获得高 40名患者的高质量肾活检。 在实施阶段UH 3，我们将增加招募并获得肾脏活检、生物样本 以及来自另外400名CKD-糖尿病和CKD-HTN患者的临床数据，增加了另一个大HCS。 我们还将扩大CKD患者的队列，根据进展的高风险可能产生可操作的结果 (eGFR 2年内下降>30%）、新的成像结果（UTSW的fMRI或SPECT）或其他 来自UG 3的KPMP研究者建议识别治疗靶点的可能性。 我们的团队在招募患者参加CKD临床试验方面的长期成功记录， 我们研究中心可招募的大量不同患者人群，功能齐全的基础设施 用于使用新的信息学工具从多个医疗保健系统中识别和招募患者， 伦理上严格的同意肾脏活检的方法加上严格安全的方法将 帮助我们为KPMP做出贡献。