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: 6112817
• 负责人: Robert S Gaston
• 金额: $ 2.95万
• 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: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6112817
• 关键词: artificial immunosuppression; azathioprine; chemoprevention; clinical research; combination chemotherapy; cyclosporines; homologous transplantation; human subject; kidney transplantation; monoclonal antibody; prednisone; transplant rejection

In kidney transplantation, immunologically-mediated rejection remains the most common cause of allograft failure. New technology has resulted in significant advances in our ability to prevent and treat rejection. These include development of antibodies which can block immune responses at very specific points. This prospective, randomized, double-blind study will evaluate the ability of a new monoclonal antibody (HAT), Humanized Anti-Tac, Hoffman-LaRoche, Inc) to reduce rejection episodes when administered along with standard three-drug immunosuppressive therapy in kidney transplant recipients. Prior to transplant surgery, recipients of first cadaveric transplants will be randomized to one of two treatment arms. The first will receive a single dose of HAT (1 mg/kg) before transplantation, with subsequent doses administered on an outpatient basis at 14, 28, 42, and 56 days posttransplant. Those randomized to the second arm will receive a placebo infusion at the same intervals. In addition to the study drug, both groups will receive standard three-drug (cyclosporine, azathioprine, prednisone) immunosuppression. The primary endpoint is incidence of acute rejection within the first 6 months posttransplant. It is anticipated that the initial dose of HAT will be given as an inpatient at UAB Hospital, with subsequent doses administered as an outpatient in the GCRC.

在肾移植中，免疫介导的排斥反应仍然是同种异体移植失败的最常见原因。 新技术使我们预防和治疗排斥反应的能力取得了重大进步。 其中包括开发可以在非常特定的点阻断免疫反应的抗体。 这项前瞻性、随机、双盲研究将评估新型单克隆抗体 (HAT)（人源化 Anti-Tac，Hoffman-LaRoche, Inc）与标准三药免疫抑制疗法在肾移植中联合使用时减少排斥反应的能力收件人。 在移植手术之前，第一次尸体移植的接受者将被随机分配到两个治疗组之一。 第一个患者将在移植前接受单剂 HAT（1 毫克/公斤），随后在移植后 14、28、42 和 56 天在门诊给药。 那些被随机分配到第二组的患者将在相同的时间间隔内接受安慰剂输注。 除了研究药物外，两组患者还将接受标准的三药（环孢素、硫唑嘌呤、泼尼松）免疫抑制治疗。 主要终点是移植后前 6 个月内急性排斥反应的发生率。 预计 HAT 的初始剂量将在 UAB 医院的住院患者中进行，随后的剂量将在 GCRC 的门诊患者中进行。