EFFICACY & SAFETY OF IV & ORAL MYCOPHENOLATE MOFETIL & AZATHIOPRINE

功效

• 批准号: 6264968
• 负责人: RUSSELL H WIESNER
• 金额: $ 2.01万
• 依托单位: MAYO CLINIC ROCHESTER
• 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/6264968
• 关键词: artificial immunosuppression; azathioprine; clinical research; clinical trial phase I; combination chemotherapy; corticosteroids; cyclosporines; human subject; human therapy evaluation; immunosuppressive; intravenous administration; liver transplantation; oral administration; transplant rejection

This is a multicenter, randomized, double-blind, double-dummy comparative study assessing the efficacy and safety of IV followed by oral mycophenolate mofetil or azathioprine, each in combination with cyclosporine (Neoral) and corticosteroids, in patients receiving their first cadaveric liver allograft. The primary objectives are 1) to demonstrate that mycophenolate mofetil reduces the proportion of patients who experience in the first six months posttransplantation (a) one or more epidoses of treated, biopsy-proven acute allograft rejection with biochemical abnormalities suggestive of rejection, or (b) death/retransplantation and 2) graft loss (death/retransplantation) during the first 12 months of posttransplantation. Since the patients recruited for the study are post-transplant and very ill, a GCRC nurse travels to Rochester Methodist Hospital to perform the blood draws for the pharmacokinetic studies. We had anticipated 80 patients, but enrollment has stopped. we are still following all patients.

这是一项多中心、随机化、双盲、双模拟比较研究，旨在评估首次接受尸体肝同种异体移植的患者接受IV给药后口服吗替麦考酚酯或硫唑嘌呤联合环孢素（Neoral）和皮质类固醇的疗效和安全性。 主要目的是：1）证明吗替麦考酚酯可降低移植后前6个月内发生（a）一次或多次经治疗的、活检证实的急性同种异体移植物排斥反应（伴有提示排斥反应的生化异常）或（B）死亡/再次移植的患者比例; 2）移植后前12个月内发生移植物丢失（死亡/再次移植）的患者比例。由于研究招募的患者为移植后且病情严重，GCRC护士前往罗切斯特卫理公会医院进行药代动力学研究的采血。 我们预计有80名病人，但招募已经停止了。 我们仍在追踪所有病人。