NCT00817687已完成4 期
A Randomised, Multicenter, Open-label Study Evaluating the Impact on the Fibrosis at Week 52 of an Early Biopsy at (D10) Versus Standard Management in Patients Who Have Undergone de Novo Renal Transplantation and Received a Marginal Organ Transplant
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 主要终点
- Proportion of patients with >=25% increase in fibrosis score
研究概览
简要总结
This 2 arm study will evaluate the impact on fibrosis at week 52 of an early biopsy, in patients who have received a kidney transplant from an expanded criteria donor. Patients will be randomized to one of two groups; the first group will have a biopsy at day 10, and the second group will receive standard management. All patients will be given CellCept as standard of care. The anticipated time on study treatment is 1 year, 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, >=18 years of age;
- •in receipt of an initial cadaveric kidney transplant;
- •in receipt of graft with biopsy;
- •in receipt of a 'marginal' kidney transplant.
排除标准
- •in receipt of a second kidney transplant;
- •in receipt of a multi-organ transplant or a double kidney transplant;
- •malignant tumor, or a history of cancer in past 5 years, other than successfully treated basal cell or spinocellular cancer or cancer in situ of cervix;
- •replicating hepatitis B and/or C, or HIV positive serology.
研究组 & 干预措施
1
Experimental
干预措施: mycophenolate mofetil [CellCept] (Drug)
2
No Intervention
干预措施: mycophenolate mofetil [CellCept] (Drug)
结局指标
主要结局
Proportion of patients with >=25% increase in fibrosis score
时间窗: Day 0 to Week 52
次要结局
- Renal function (creatinine clearance)(From randomization to Week 52)
- Incidence and time of occurrence of clinical acute rejection(From randomization to Week 52)
- Adverse events, laboratory parameters, cancers and lymphoproliferative syndromes(Throughout study)
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