A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Efficacy and Safety of up to 100 Days of Valganciclovir Versus up to 200 Days of Valganciclovir for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Kidney Allograft Recipients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 80
- 主要终点
- Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant
研究概览
简要总结
This study will determine the relative efficacy and safety of up to 100 days Valcyte prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of CMV disease in high-risk (D+/R-) kidney allograft recipients. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 16 years of age
- •CMV seronegative recipient of primary or secondary renal allograft from a living or cadaveric seropositive donor
- •Adequate hematological and renal function
- •Patients and partners must agree to maintain effective birth control for 90 days following cessation of study medication
排除标准
- •CMV disease, or receipt of anti-CMV therapy within 30 days prior to screening
- •Multi-organ transplant recipient
- •Hepatitis B, hepatitis C or HIV positive
- •Women who are pregnant or lactating
研究组 & 干预措施
Valganciclovir up to 100 days
Valganciclovir for up to 100 days post kidney transplant
干预措施: Valganciclovir (Drug)
Valganciclovir up to 200 days
Valganciclovir for up to 200 days post kidney transplant
干预措施: Valganciclovir (Drug)
结局指标
主要结局
Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant
时间窗: 12 months post-transplant
Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 12 months post-transplant.
次要结局
- Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant(24 months post-transplant)
- Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant(6 months post-transplant)
- Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant(9 months post-transplant)
- Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant(18 months post-transplant)