ANTI TAC WITH 3 DRUG THERAPY FOR PREVENTION OF ACUTE ALLOGRAFT REJECTION

抗 TAC 联合 3 种药物治疗预防急性同种异体移植排斥

• 批准号: 6274051
• 负责人: Robert S Gaston
• 金额: $ 2.59万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-01-26 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6274051
• 关键词: artificial immunosuppression; azathioprine; chemoprevention; clinical research; combination chemotherapy; cyclosporines; homologous transplantation; human subject; kidney transplantation; monoclonal antibody; prednisone; transplant rejection

Acute rejection remains a vexing problem in renal transplantation: it is the most common cause of transplant failure and its therapy results in significant adverse events. Humanized anti-TAC (HAT) is a new monoclonal antibody which has been shown in a pilot trial to be effective in preventing acute rejection with minimal side effects. In this multicenter trial, 260 patients at 20 transplant centers in the US and Canada will be randomized to receive either standard three-drug immunosuppressive therapy (cyclosporine, azathioprine, prednisone) or the same drugs along with HAT to prevent rejection during the first 90 days following transplant. HAT has unique characteristics which allow it to be administered every 14 days. The first dose is given during the transplant operation. Doses 2-5 (at 2, 4, 6, and 8 weeks posttransplant) require outpatient assessment and administration. These visits occur in the GCRC, where each patient undergoes a physical exam, laboratory evaluation of allograft function, insertion of an intravenous catheter, and administration of study drug in a controlled environment. The endpoint of this blinded trial is frequency of acute rejection within the first six months following transplant. At the current time, the study remains blinded, with no results available. So far, twenty-one patients have been enrolled at UAB.

急性排斥反应仍然是肾移植中一个令人烦恼的问题： 移植失败的最常见原因及其治疗结果 重大不良事件。 人源化抗 TAC (HAT) 是一种新型单克隆抗体 初步试验表明该抗体可有效 以最小的副作用预防急性排斥反应。 在这个多中心 试验中，美国和加拿大 20 个移植中心的 260 名患者将接受 随机接受标准三药免疫抑制治疗 （环孢素、硫唑嘌呤、泼尼松）或与 HAT 一起使用的相同药物 以防止移植后前 90 天内出现排斥反应。 帽子 具有独特的特性，每 14 次进行一次 天。 第一剂是在移植手术期间给予的。 剂量 2-5 （移植后 2、4、6 和 8 周）需要门诊评估和 行政。 这些就诊发生在 GCRC，每个患者都在那里 接受体检、同种异体移植功能的实验室评估， 插入静脉导管并给予研究药物 受控环境。 该盲法试验的终点是频率 移植后头六个月内发生急性排斥反应。 在 目前，该研究仍处于盲法状态，没有任何结果。 到目前为止，UAB 已有 21 名患者入组。