ORAL SOLUTIONS OF SANG35 VERSUS NEORAL IN STABLE ADULT RENAL ALLOGRAFTS

SANG35 与 NEORAL 在稳定成人肾同种异体移植物中的口服溶液

• 批准号: 6112875
• 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/6112875
• 关键词: clinical research; cyclosporines; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; immunosuppressive; kidney disorder chemotherapy; kidney transplantation; oral administration; pharmacokinetics; transplant rejection

Acute rejection remains the most important clinial problem facing transplant patients, and is still the most frequent cause of allograft failure. In addition, treatment of an acute rejection episode with even higher doses of immunosupressive drugs can lead to over-immunosuppression and life-threatening complications. Since gaining FDA approval in 1983, cyclosporine has improved renal allograft survival rates by reducing the incidence of acute rejection episodes. Sandoz Pharmaceuticals discovered and introduced cyclosporine into clinical practice as the liquid formulation, Sandimmune. In 1995, Sandoz introduced a new microemulsion formulation, Neoral, with substantially enhanced pharmacokinetic characteristics. Cyclosporine, the most potent and specific immunosupressant ever developed, revolutionized renal transplantation. Unfortunately, the cost of this drug, for most patients, is in excess of $5,000 per year. In 1996, its patent expired, opening the door for generic equivalents. The purpose of this study is to demonstrate, in renal transplant recipients, that a new generic cyclosporine formulation, SANG-35, is equal in terms of safety, tolerability, and pharmacokinetic profile with the FDA-approved and currently marketed Neoral. The anticipation of the sponsoring company is that such a compound, if acceptable to the transplant community, could be marketed at a substantial discount to currently available cyclosporine formulations.

急性排斥反应仍然是移植患者面临的最重要的临床问题，并且仍然是同种异体移植失败的最常见原因。 此外，用更高剂量的免疫抑制药物治疗急性排斥反应可能会导致过度免疫抑制和危及生命的并发症。 自 1983 年获得 FDA 批准以来，环孢素通过降低急性排斥反应的发生率，提高了肾同种异体移植物的存活率。 山德士制药公司发现了环孢素并将其作为液体制剂 Sandimmune 引入临床实践。 1995年，山德士推出了一种新的微乳液制剂Neoral，其药代动力学特性显着增强。环孢菌素是迄今为止开发的最有效和特异性的免疫抑制剂，彻底改变了肾移植。 不幸的是，对于大多数患者来说，这种药物的费用每年超过 5,000 美元。 1996 年，其专利到期，为通用等效产品打开了大门。 本研究的目的是证明，在肾移植受者中，新的仿制环孢素制剂 SANG-35 在安全性、耐受性和药代动力学特征方面与 FDA 批准的目前上市的 Neoral 相同。 赞助公司的预期是，如果移植界可以接受，这种化合物可以以比目前可用的环孢菌素制剂大幅折扣的价格出售。