跳至主要内容
临床试验/NCT00531440
NCT00531440已完成3 期

A 2 Year Extension to a 1 Year Multicenter, Randomized, Open Label, Parallel Group Study of the Safety, Tolerability and Efficacy of Two Doses (1.5 and 3 mg/Day) of Everolimus (RAD001) With Basiliximab, Corticosteroids and Optimized Administration of Cyclosporine in de Novo Renal Transplant Recipients.

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2001年11月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
256
试验地点
1
主要终点
graft loss, death, biopsy-proven acute rejection,antibody-treated ,biopsy-proven chronic allograft nephropathy,retransplantation/dialysis up to 36m renal function measured by creatinine clearance Cockcroft-Gault)calculated glomerularfiltration rate

研究概览

简要总结

This extension study is designed to provide long-term safety and efficacy data beyond 12 months up to Month 36.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are receiving study medication at Month 12 (CRAD001A2307) and sign a new Informed Consent to extend the treatment or observation period beyond Month
  • Female patients must agree to continue using an approved method of birth control throughout the study and for 3 months following the last dose of study medication.
  • Another Informed Consent was required for the extension amendment. This Informed Consent allowed for separate consent to the amendment study itself, and the retrospective collection of biopsies and/or the yearly protocol biopsies.
  • Inclusion and exclusion criteria were not changed, except that patients who completed the core study in follow-up became eligible to participate in the amended extension.

排除标准

  • Patients who are receiving study medication and do not sign a new Informed Consent to extend the treatment and observation period beyond Month 12 cannot enter the extension.

结局指标

主要结局

graft loss, death, biopsy-proven acute rejection,antibody-treated ,biopsy-proven chronic allograft nephropathy,retransplantation/dialysis up to 36m renal function measured by creatinine clearance Cockcroft-Gault)calculated glomerularfiltration rate

次要结局

  • biopsy-proven acute rejection episodes,graft loss, deathor lost to follow-up 6,12,24&3677 Mths both groups.assess the incidence of graft loss, death, biopsy-proven acute rejection, antibody-treated acute rejection, clinically-confirmed acute rejection.

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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