An Open Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Early Calcineurin Inhibitor Withdrawal in Recipients of Primary Renal Allografts Maintained Long-term on Mycophenolate Mofetil (MMF) (CellCept®) and Sirolimus (Rapamune®)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 305
- 主要终点
- Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12
研究概览
简要总结
This 2-arm study recruited kidney transplant patients who were receiving standard care of calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g twice daily) and corticosteroids. They were either randomized to continue this regimen, or CNI therapy was discontinued and replaced by sirolimus therapy (in combination with CellCept and corticosteroids). The effect of these 2 regimens on efficacy, safety and kidney function was evaluated. The anticipated time on study treatment was 1-2 years, and the target sample size was 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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 18-75 years of age
- •Kidney transplant 30-180 days post-transplantation
- •Receipt of cyclosporine or tacrolimus, CellCept, and corticosteroids for greater than 14 days prior to study entry
- •No known contraindications to sirolimus
排除标准
- •Multiple organ transplant recipients or secondary kidney transplant recipients
- •Corticosteroid-resistant rejection episode within 90 days prior to study entry or corticosteroid-sensitive rejection episode within 30 days prior to study entry
- •More than 1 biopsy-proven episode of acute rejection prior to study entry
- •Treated with sirolimus before the study
- •Organ transplant or expected organ transplant, other than kidney
- •History of malignancy in the last 5 years (except successfully treated localized non-melanotic skin cancer)
研究组 & 干预措施
2
干预措施: Calcineurin inhibitors (Drug)
1
干预措施: mycophenolate mofetil [CellCept] (Drug)
1
干预措施: Corticosteroids (Drug)
1
干预措施: Sirolimus (Drug)
2
干预措施: mycophenolate mofetil [CellCept] (Drug)
2
干预措施: Corticosteroids (Drug)
结局指标
主要结局
Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12
时间窗: baseline to 12 months
The primary efficacy endpoint was mean percent change in renal function from baseline to 12 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate. percent change= \[(Glomerular Filtration Rate at Month 12-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline\]\*100 percent.
次要结局
- Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24(Baseline to 24 months)
- Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24(baseline, 6, 12, and 24 months)
- Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24(baseline 6, 12, and 24 months)
- Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation)(baseline, 6, 12, and 24 months)