NCT00374647已完成4 期
Open Label Randomized Single Study to Evaluate the Safety & Efficacy of Early CNI Withdrawal in Recipients of Primary Renal Allografts Maintained Long-Term on Mycophenolate Mofetil; MMF (CellCept) and Sirolimus (Rapamune)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- Composite endpoint of either acute rejection, biopsy proven calcineurin inhibitor toxicity, or failure of the estimated BSA indexed GFR by MDRD method to improve by 20% from time randomization to 12 months.
研究概览
简要总结
Evaluate the safety and efficacy of early corticosteroid withdrawal and simultaneous calcineurin inhibitor withdrawal in recipients of primary renal allografts maintained long-term on MMF and sirolimus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Male and female patients between 18 and 75 years of age.
- •Patients who are 90 to 240 days after having received a primary living or cadaver renal allograft.
- •Patients maintained on a regimen of cyclosporine or tacrolimus and MMF since transplantation.
- •Capable of providing written informed consent.
- •No known contraindications to treatment with sirolimus.
排除标准
- •Pregnant or lactating.
- •Acute rejection within 90 days prior to study randomization.
- •More than one biopsy proven acute rejection episode prior to study randomization.
- •Previously received or are receiving an organ transplant other than kidney.
- •Receiving sirolimus prior to entry.
- •Severe diarrhea or other gastrointestinal disorders that may interfere with their ability to absorb oral medication.
- •Evidence of active systemic infection requiring antibiotics, or HIV, HCV, HBV infection.
- •History of malignancy in the past 5 years.
- •Require dialysis at the time of study entry.
结局指标
主要结局
Composite endpoint of either acute rejection, biopsy proven calcineurin inhibitor toxicity, or failure of the estimated BSA indexed GFR by MDRD method to improve by 20% from time randomization to 12 months.
次要结局
- Incidence of biopsy proven acute rejection at 6 and 12 months.
- Total number of rejection episodes per patient.
- Graft loss and patient death.
- Incidence of treatment failure.
- Renal allograft function at 6 and 12 months.
- Time to first rejection.
研究者
E. Steve Woodle
Professor
University of Cincinnati
研究点 (4)
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