NCT00478608已完成3 期
A Clinical Study to Evaluate the Efficacy and Safety of Cyclosporine (CsA) and Sirolimus (SRL) Induction Followed by Cyclosporine Withdrawal in Korean Renal Allograft Recipients
Wyeth is now a wholly owned subsidiary of Pfizer9 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2007年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 9
- 主要终点
- Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation.
研究概览
简要总结
Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients.
Secondary :
- To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal transplantation recipients.
- To evaluate graft function, patient survival and graft survival at 6 and 12 months after transplantation, and to investigate the incidence of biopsy-confirmed acute rejection episode at 12 months after transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 13 years of age.
- •End-stage renal disease in patients scheduled to receive a primary renal allograft from a cadaveric donor, a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor. A mismatch donor is defined as a donor human leukocyte antigen (HLA) antigen not shared by the patient.
- •Patients with a panel of reactive antibody (%PRA) less than or equal to 50%
排除标准
- •Evidence of active systemic or localized major infection at the time of initial sirolimus administration.
- •Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening.
- •Chronic anti-arrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery.
- •History of malignancy within 5 years before enrollment into the study (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin).
- •Current treatment with partial opioid agonists (eg, buprenorphine) or combination agonists/antagonists.
结局指标
主要结局
Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation.
时间窗: 6 months after transplantation
The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).
次要结局
- Glomerular Filtration Rate (GFR) (Nankivell Method)(6 and 12 months)
- Serum Creatinine(Baseline, 6 and 12 months)
- Patient and Graft Survival(12 months)
- Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 12 After Transplantation(12 months after transplantation)
研究者
研究点 (9)
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