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临床试验/NCT01469884
NCT01469884已完成4 期

A Prospective, Single-center, Open-label, Pilot Study to Investigate the Effect of Switching to Certican® in Viremia of Hepatitis C Virus in Adult Renal Allograft Recipients.

Irmandade Santa Casa de Misericórdia de Porto Alegre1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Change from baseline in viral load of hepatitis C virus at 12 months after randomization.

研究概览

简要总结

Compare the viral load of hepatitis c virus in patients converted to certican versus patients who are maintained on calcineurin inhibitor.

详细描述

The infection by hepatitis C virus (HCV) is the leading cause of chronic liver disease in renal transplant recipients.

The prevalence of pretransplantation anti-HCV is 11% to 49%. The impact of HCV infection on patient survival after renal transplant remains controversial. Some studies also showed that patients undergoing renal transplantation anti-HCV positive are associated with a reduction in graft and patient survival.Chronic infection of HCV is associated with an increased number of infections.

In HCV positive renal transplant patients have been shown that there is an increase from four to seven times in HCV viremia after transplantation compared to pretransplant.

To prevent viral replication, immunosuppression must be adapted, involving a balance between control of viral replication and rejection.

Biochemically, the NS5A protein has been linked to increased replication of the hepatitis C virus through p70S6K phosphopeptides. Sirolimus as inhibitor of pathway mTOR/p70S6K reduced in vivo phosphorylation of NS5A phosphopeptides and thus viral replication. Moreover, the mTOR protein has been proven in vitron to have a protective role against apoptosis in HCV infected cells (WAGNER et al., 2010).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Certican®

Experimental

Arm1(conversion):Certican®+mycophenolate+prednisone

干预措施: Everolimus (Drug)

Tacrolimus or Cyclosporine

Active Comparator

Arm2(maintained):Tacrolimus or Cyclosporine+mycophenolate+prednisone

干预措施: Cyclosporine (Drug)

Tacrolimus or Cyclosporine

Active Comparator

Arm2(maintained):Tacrolimus or Cyclosporine+mycophenolate+prednisone

干预措施: Tacrolimus (Drug)

结局指标

主要结局

Change from baseline in viral load of hepatitis C virus at 12 months after randomization.

时间窗: Baseline,Months 3, 6, 9 and 12 after randomization

HCV viremia will be measured by polymerase chain reaction (PCR)

次要结局

  • Incidence of acute allograft rejection(Weeks 1, 2, 3, months 1, 3, 6, 9 and 12 after randomization)
  • Incidence of significant infections(Weeks1, 2, 3 and months 1, 3, 6,9 and 12 after randomization)
  • Development of proteinuria(Months 1, 3, 6, 9 and 12 after randomization)
  • Development of malignance(Weeks 1, 2, 3 and months 1, 3, 6, 9 and 12 after randomization)
  • Development of dyslipidemia(Months 1, 3, 6, 9 and 12 after randomization)
  • Development of liver impairment(Months 1, 3, 6, 9, and 12 after randomization)
  • Development of post-transplant diabetes(Months 1, 3, 6, 9 and 12)
  • Development of hypertension(Weeks 1, 2, 3 and months 1, 3, 6, 9 and 12 after randomization)
  • Graft loss survival(Weeks 1, 2 , 3 and months 1, 3 ,6, 9 and 12 after randomization)
  • Patient survival(Weeks 1, 2, 3 and months 1, 3, 6, 9 and 12 after randomization)

研究者

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

Valter Duro Garcia

PHYSICIAN NEPHROLOGY

Irmandade Santa Casa de Misericórdia de Porto Alegre

研究点 (1)

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