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临床试验/NCT04906304
NCT04906304已完成不适用

Comparison of Safety and Efficacy of de Novo Everolimus Plus Low Dose of Cyclosporine With Standard Dose of Cyclosporine Plus Cellcept on CMV and BK Virus Infections Prevention in Renal Transplant Patients

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2020年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
CMV Infection

研究概览

简要总结

Nowadays, de novo everolimus regimen in renal transplant patients is considered for reduction of cyclosporine dose and it is mentioned that this regimen not only has similar safety and efficacy, but also could prevent Cytomegalovirus (CMV )infections. So, the aim of this study was comparison of safety and efficacy of de novo everolimus plus low dose of cyclosporine with standard dose of cyclosporine plus cellcept on CMV virus infections prevention in renal transplant patients.

详细描述

This randomized clinical trial was conducted in Shahid Labbafi nejad hospital. 35 renal transplanted patients enter the study and randomized to one of two groups: everolimus or control (Sandimmun or tacrolimus). However, 34 patients completed study (17 patients in each group). The treatment regimen in everolimus group was 0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral) low dose and in control group was standard dose of Sandimmun or tacrolimus plus cellcept. All patients gave Antithymocyte Glubolin and prednisolone. In addition, they gave CMV prophylaxis until 3 months. Kidney biopsies were done for raise of creatinine or protocol biopsy at 6 month after transplantation. Demographic, renal disease and transplantation characteristics, CMV and BK virus status, rejection, and routine laboratory tests recorded during study period and compared between two groups.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult Transplanted patients > 18 years

排除标准

  • Simultanous Kidney -Pancreas Transplantation

研究组 & 干预措施

Evrolimus

Experimental

The treatment regimen in everolimus group was 0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral) low dose pluse cellcept

干预措施: Everolimus Pill (Drug)

Evrolimus

Experimental

The treatment regimen in everolimus group was 0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral) low dose pluse cellcept

干预措施: Sandimmun (Neoral) dose plus cellcept (Drug)

Control

Active Comparator

0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral)standard dose plus cellcept

干预措施: Everolimus Pill (Drug)

Control

Active Comparator

0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral)standard dose plus cellcept

干预措施: Sandimmun (Neoral) dose plus cellcept (Drug)

结局指标

主要结局

CMV Infection

时间窗: 6 months

CMV PCR quantitative count

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

nooshin dalili

assistant Professor of SBMU

Shahid Beheshti University of Medical Sciences

研究点 (1)

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