NCT00141804Unknown3 期
A Randomized Multicenter Study to Compare Tacrolimus and MMF With Tacrolimus and Rapamycin in Patients After Renal Transplantation
University Hospital Muenster2 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2002年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- - time to first biopsy proven acute rejection episode at month 12
研究概览
简要总结
To study the efficacy and safety of the administration of Tacrolimus in combination with Sirolimus for the prevention of acute rejection in patients after renal transplantation
详细描述
Basic randomized clinical trial (multicentre) in primary KTX to assess the safety and efficacy of a tac/rapa vs a tac/MMF regimen. Tac trough levels in accordance with current standards in both arms. Steroids to be used to individual centre protocol. Rapa trough levels will be adjusted to 5-10 ng/ml. Up to now only few data (primate and clinical) on tac/rap combinations available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first kidney transplantation
- •re-transplantation
- •non-related living donor transplantation
- •patients > 18 years
- •patients have given their written consent after being informed
- •female patients in the age of parity must consent to an effective birth control and submit a negative pregnancy test
排除标准
- •related living donation
- •patients with known HIV-anamnesis
- •patients who need systemically administered immunosuppression for another indication than the prophylaxis of kidney graft rejection
- •patients with present malignant disease
- •patients with clinically significant, uncontrolled infectional disease and/or severe diarrhea, vomiting or active gastric ulcer
- •patients who haven taken part in a clinical study in the past 28 days and/or receive (received) medication which is not licensed by the responsible health authority
- •other reasons which depend on the assessment of the physician
结局指标
主要结局
- time to first biopsy proven acute rejection episode at month 12
- graft failure at month 12
- discontinuation of study medication at month 12
次要结局
- - patient and graft survival at month 12
- - incidence and severity of biopsy proven acute rejection episodes and incidence of steroid-resistant acute rejection episodes at month 12
- - Renal function at month 12 (S-creatinine, Cockgroft-Gault clearance)
- - incidence and severity of infections at month 12
- - incidence of adverse events at month 12
研究者
研究点 (2)
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