Atlanta Sickle Cell Disease Clinical Research Consortium

亚特兰大镰状细胞病临床研究联盟

• 批准号: 7059789
• 负责人: Peter Anthony Lane
• 金额: $ 16.81万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-17 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7059789
• 关键词: analgesics; blood disorder chemotherapy; clinical research; clinical trial phase III; cooperative study; dosage; human subject; human therapy evaluation; kidney disorder; kidney disorder chemotherapy; losartan; medical complication; pain; patient oriented research; sickle cell anemia; sickle cell crisis

DESCRIPTION (provided by applicant): The purpose of the RFA for a Sickle Cell Disease (SCD) 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 SCD 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 SCD 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 continuous 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 SCD. Two proposed projects will improve treatment of pain, the most common and disabling manifestation of SCD and lessen the impact of chronic kidney disease. (End of abstract)

描述（由申请人提供）： RFA for a Sickle Cell Disease（SCD）临床研究网络（CRN）的目的是建立一个由15个临床中心组成的基础设施，这些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局。来自埃默里和莫尔豪斯医学院的临床研究人员建议在亚特兰大建立15个临床中心之一。该提案包括三个要素： 临床研究核心将有助于SCD CRN研究的设计和实施，并在亚特兰大儿童保健和格雷迪卫生系统招募受试者。 项目1将检验血管紧张素受体拮抗剂氯沙坦可降低镰状肾病患者肾脏疾病进展率的假设。该假设将在两组中进行检验：大量白蛋白尿和明显肾病患者，以及微量白蛋白尿患者。除了确定对进行性肾脏疾病的影响外，本研究还将比较氯沙坦与安慰剂在镰状细胞肾病蛋白尿患者中长期给药的安全性和耐受性。 项目2是一项前瞻性III期随机试验，旨在检验纳布啡在治疗SCD中血管闭塞性疼痛方面上级吗啡的假设，因为患者将遭受较少的急性胸部综合征发作，并且由于较少的呼吸抑制和组胺释放减少而遭受较少的副作用。第二个假设是，高剂量PCA与低剂量输注镇痛剂相比，上级PCA与高剂量输注效果更好。将通过一项四组研究对这一假设进行检验，该研究将比较吗啡与纳布啡以及每种镇痛剂的低剂量连续输注+高剂量PCA与高剂量输注+低剂量PCA。 CRN的工作将对减少SCD并发症的发病率和死亡率做出重要贡献。两个拟议的项目将改善疼痛的治疗，这是SCD最常见和致残的表现，并减轻慢性肾脏疾病的影响。(End摘要）