The Comparison Between Clinical and Paraclinical Effect of Iminoral Vs Neoral in Prevention of Acute Rejection in the First Year Afer Transplantation in De Novo Renal Transplant Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- transplanted kidney acute rejection
研究概览
简要总结
Cyclosporine is the key drug in organ transplantation. In Iran the investigators have more than 2500 new renal transplantation each year and because of this the government pay a huge amount of money for subsiding the imported cyclosporine in the form of Neoral. Recently an Iranian drug company introduced this drug in the name of Iminoral which has been approved by different authorities in Iran and abroad, (including the Ministry of Health in Iran and also European Directorate for the Quality of Medicines Certification Unit and FDA(Department of Health and Human Services,Center for Drug Evaluation and Research)). The investigators study is the first clinical trial to compare the effect of Iminoral versus Neoral in preventing acute rejection in renal transplantation and also to compare the side effects of these two drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •renal transplantation candidates
- •written consent
- •not taking participate in any other clinical trial in last 3 months
排除标准
- •primary FSGS
- •hyperoxaluria
- •age under 18
- •multi organ transplantation
- •any malignancy in 5 years
- •use of Tacrolimus
- •hyper acute rejection
研究组 & 干预措施
1
taking Iminoral
干预措施: Iminoral (Drug)
2
taking Neoral
干预措施: Neoral (Drug)
结局指标
主要结局
transplanted kidney acute rejection
时间窗: one year
次要结局
- cyclosporine side effects(one year)
研究者
Mohammad Reza Khatami
Associate professor
Imam Khomeini Hospital