Atlanta Sickle Cell Disease Clinical Research Consortium
Atlanta Sickle Cell Disease Clinical Research Consortium
批准号:
7393088
负责人:
Peter Anthony Lane
金额:
$31.96万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2006
资助国家:
美国
项目状态:
已结题
起止时间:
2006-04-17 至 2011-03-31
关键词:
AdolescentAdultAdverse effectsAnalgesicsAngiotensin IIAngiotensin ReceptorAreaAwardCaringChildChildhoodChronic Kidney FailureClinicClinicalClinical InvestigatorClinical ResearchClinical TrialsClinical Trials DesignCollaborationsConduct Clinical TrialsDataData QualityDiscipline of NursingDoctor of PhilosophyDoseDouble-Blind MethodElementsEnrollmentEnvironmentFundingHealthHealth systemHealthcareHistamine ReleaseInfusion proceduresKidney DiseasesLosartanMicroalbuminuriaMorbidity - disease rateMorphineMulti-Institutional Clinical TrialNalbuphineNumbersOutcomePainPatientsPerformancePersonsPhasePlacebosPopulationPrevention strategyPrincipal InvestigatorPurposeRandomizedRandomized Controlled Clinical TrialsRateRecruitment ActivityResearch InfrastructureResearch PersonnelSafetySickle CellSickle Cell AnemiaStructureTestingTherapy Clinical TrialsUniversitiesUpper armWorkacute chest syndromedesignexperienceimprovedmacroalbuminuriamedical schoolsmortalityprofessorprospectiverespiratorysicklingsuccess
中文摘要
镰状细胞病(SCO)临床研究网络(CRN)RFA的目的是建立一个
基础设施与15个临床中心,将设计和执行多中心治疗试验,以改善
镰状细胞病患者的健康结果。埃默里和莫尔豪斯的临床研究者
医学院建议在亚特兰大建立15个临床中心之一。这项提议包括
三个要素:
临床研究核心将有助于SCO CRN研究的设计和实施,
亚特兰大儿童保健和格雷迪卫生系统的受试者。
项目1将检验一种血管紧张素受体拮抗剂氯沙坦将降低
镰状肾病患者的肾脏疾病进展。假设将在两个
组:大量白蛋白尿和明显肾病患者以及微量白蛋白尿患者。在
除了确定对进行性肾病的影响外,该研究还将比较
氯沙坦与安慰剂在镰状细胞白蛋白尿患者中长期给药的耐受性
肾病
项目2是一项前瞻性III期随机试验,旨在检验纳布啡上级于
吗啡在治疗SCO的血管闭塞性疼痛,因为患者将遭受更少的急性发作
胸部综合征,并会遭受较少的副作用,因为较少的呼吸抑制和减少
释放组胺。第二个假设是,高剂量PCA与低剂量镇痛剂输注,
上级优于低剂量PCA和高剂量输注。这一假设将通过一项四臂研究进行检验,
比较吗啡与纳布啡和低剂量持续输注与高剂量PCA与高剂量PCA
每种镇痛剂均输注低剂量PCA。
CRN的工作将为减少并发症的发病率和死亡率做出重要贡献。
上合组织两个两个拟议的项目将改善治疗疼痛,最常见的和禁用
慢性肾脏病的治疗方法有哪些?
英文摘要
The purpose of the RFA for a Sickle Cell Disease (SCO) Clinical Research Network (CRN) is to establish an
infrastructure with 15 clinical centers that will design and perform multi-center therapeutic trials to improve
health outcomes in persons with sickle cell disease. Clinical investigators from the Emory and Morehouse
Schools of Medicine propose to establish one of the 15 clinical centers in Atlanta. The proposal includes
three elements:
The Clinical Research Core will contribute to the design and implementation of SCO CRN studies, and enroll
subjects at Children's Healthcare of Atlanta and the Grady Health System.
Project 1 will test the hypothesis that losartan, an angiotensin receptor antagonist, will reduce the rate of
progression of renal disease in patients with sickle nephropathy. The hypothesis will be tested in two
groups: patients with macroalbuminuria and overt nephropathy, and patients with microalbuminuria. In
addition to determining the effect on progressive renal disease, the study will compare the safety and
tolerability of losartan vs. placebo when administered long-term in albuminuric patients with sickle cell
nephropathy.
Project 2 is a prospective phase III randomized trial to test the hypothesis that nalbuphine is superior to
morphine in the treatment of vaso-occlusive pain in SCO because patients will suffer fewer episodes of acute
chest syndrome and will suffer fewer side effects because of less respiratory suppression and reduced
release of histamine. A second hypothesis is that high-dose PCA with low-dose infusion of analgesic is
superior to low-dose PCA with high-dose infusion. The hypothesis will be tested by a four-arm study that will
compare morphine to nalbuphine and low-dose constinuous infusion with high-dose PCA to high-dose
infusion with low-dose PCA for each analgesic.
The work of the CRN will contribute importantly to lessening morbidity and mortality from complications of
SCO. Two two proposed projects will improve treatment of pain, the most common and disabling
manifestation of SCO and lessen the impact of chronic kidney disease.
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Atlanta Sickle Cell Disease Clinical Research Consortium
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批准号:7059789
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项目类别:
-
资助金额:$16.81万
-
财政年份:2006
-
负责人:Peter Anthony Lane
-
依托单位:
Atlanta Sickle Cell Disease Clinical Research Consortium
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批准号:7224150
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项目类别:
-
资助金额:$16.69万
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财政年份:2006
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负责人:Peter Anthony Lane
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依托单位:
MEMBRANES OF NORMAL & ABNORMAL HUMAN NEONATAL RED CELLS
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批准号:3047913
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项目类别:
-
资助金额:$3.3万
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财政年份:1986
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负责人:Peter Anthony Lane
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依托单位:
MEMBRANES OF NORMAL & ABNORMAL HUMAN NEONATAL RED CELLS
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批准号:3047912
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项目类别:
-
资助金额:$3.3万
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财政年份:1985
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负责人:Peter Anthony Lane
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依托单位:
海外基金