TRANSPLANT STUDY

移植研究

• 批准号: 2066538
• 负责人: ARTHUR J MATAS
• 金额: $ 37.87万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-09-01 至 1996-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2066538
• 关键词: FK506; azathioprine; blood chemistry; clinical trials; cooperative study; creatinine; cyclosporines; drug adverse effect; drug screening /evaluation; health care cost /financing; histocompatibility; hospital length of stay; human subject; human therapy evaluation; immunosuppression; immunosuppressive; infection; kidney function; kidney transplantation; macrolide antibiotics; monoclonal antibody; neoplasm /cancer; postmortem; postoperative complications; prednisone; statistics /biometry

Multiple new immunosuppressive drugs are becoming available for prevention of rejection in renal transplant recipients. Determining which of these agents provides the best immunosuppressive protocol will require large number of patients. An individual center will be unable to generate such information. Multi-center studies such as that proposed will provide evaluation of these agents at a much more rapid pace and will thus permit the rapid dissemination of this new technology. We propose that the cooperative trial initiate randomized study of FK506 versus cyclosporine in a sequential therapy protocol. Cadaver transplant recipients will receive prednisone and azathioprine at the time of surgery with antilymphocyte globulin (ALG) started on the first post operative day. Patients will be stratified for delayed graft function (DGF), diabetes, transplant number (primary or retransplant), and for retransplants whether the first graft was lost at < vs > 1 year, and will be randomized to receive either cyclosporine or FK506 beginning on the 5th post operative day. We will assess patient and graft survival, persistence of DGF, serum creatinines at 1 week, 2 week, 1 month and monthly thereafter, incidence of complications, drug side effects, infections, rejection episodes, and malignancies. We propose that evaluation of this agent be followed by evaluation of Rapamycin, Deoxyspergualin, Mizoribine, and Succinylacetone as either FK506/cyclosporine substitutes or as azathioprine substitutes. In addition, the new monoclonal antibodies could be utilized in a randomized arm versus ALG. However, each of these studies would compare a new agent or combination of agents against best known therapy.

多种新的免疫抑制药物已用于预防 对肾移植受者的排斥。 确定其中哪一个 代理提供最佳的免疫抑制协议将需要大的 患者数量。 单个中心将无法产生这样的 信息。诸如提议的多中心研究将提供 评估这些代理的步伐要快得多，因此将允许 这项新技术的快速传播。 我们建议 合作试验启动FK506与环孢素的随机研究 顺序治疗方案。尸体移植者将收到 抗脑细胞手术时，泼尼松和硫唑嘌呤 Globulin（ALG）在第一个作战日开始。 患者会 分层以延迟移植功能（DGF），糖尿病，移植数 （初级或后期植物），对于再载植物，无论是第一个移植物是否 在<vs> 1年失去了 环孢素或FK506从第五次后期手术日开始。我们将 评估患者和移植物的生存，DGF的持久性，血清肌酐 1周，2周，1个月，然后每月，并发症发生率， 药物副作用，感染，排斥发作和恶性肿瘤。 我们 提出对该代理的评估之后进行评估 雷帕霉素，脱氧蛋白酶，米佐替替替替替替替替替替替替替替替替替替替啶， FK506/环孢菌素替代品或硫唑嘌呤替代品。 在 此外，新的单克隆抗体可以随机使用 手臂与ALG。 但是，这些研究中的每一个都将比较一个新的代理 或反对最知名疗法的药物的组合。