NCT00121784终止4 期
A Randomized, Open-label Study of the Effect of Replacing CNI With Sirolimus in a Standard Care Regimen of CNI, CellCept, and Steroids on Renal Function in Heart Transplant Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 12
- 主要终点
- Renal function assessed by calculated GFR at 24 months post-transplant, and incidence of biopsy-proven acute rejection (BPAR) or HDC, graft loss or lost to follow-up\n
研究概览
简要总结
Heart transplant patients on a standard care regimen of CNI, MMF, and corticosteroids will enter the study 4-6 weeks post-transplant. At 3 months after transplant, patients will be randomized to either continue this regimen or CNI therapy will be discontinued and replaced by sirolimus therapy (in combination with MMF and corticosteroids). The effect of these 2 regimens on efficacy, safety and renal function will be evaluated.The anticipated time on study treatment is 1-2 years and the target sample size is 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 (>=18 years of age) heart transplant patients (4-6 weeks post-transplant);
- •receipt of first heart (single-organ) transplant;
- •standard care regimen of CNI, MMF, and corticosteroids since transplantation.
排除标准
- •positive donor-specific cross-match at time of transplantation;
- •history of malignancies, other than non-melanoma skin cancer that has been totally excised with no recurrence for 2 years;
- •patients participating in another interventional clinical trial or requiring treatment with unmarketed investigational drugs.
研究组 & 干预措施
1
Experimental
1
干预措施: mycophenolate mofetil [CellCept] (Drug)
结局指标
主要结局
Renal function assessed by calculated GFR at 24 months post-transplant, and incidence of biopsy-proven acute rejection (BPAR) or HDC, graft loss or lost to follow-up\n
次要结局
- Incidence of BPAR, number of episodes of BPAR per patient, time to first BPAR, incidence of re-transplant, death, rejection including antibody treated rejection, time to graft loss or death, rejection associated with HDC\n
研究者
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