NCT00129961已完成4 期
A Randomized, Open-Label Study to Compare the Rate of New Non-Melanoma Skin Cancer in Maintenance Renal Allograft Recipients Converted to a Sirolimus-based Regimen Versus Continuation of a Calcineurin Inhibitor-based Regimen
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 86 人开始时间: 2005年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 主要终点
- New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year
研究概览
简要总结
The purpose of this study is to determine the effect of sirolimus on the prevention of new non-melanoma skin cancer (NMSC) in kidney transplant recipients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplant at least 1 year prior
- •Subjects with a functioning renal allograft with calculated glomerular filtration rate (GFR) ≥40mL/min (Nankivell method) and proteinuria ≤500mg/day.
- •Stable on cyclosporine or tacrolimus-based multi-drug immunosuppressive regimen
- •History of NMSC within last 3 years
排除标准
- •History of other cancer within last 3 years
- •NMSC with metastatic disease or more than 20 NMSC lesions in last 12 months
- •Multiple organ transplant
研究组 & 干预措施
1
Experimental
Conversion to a sirolimus-based regimen
干预措施: sirolimus (Drug)
2
Active Comparator
Continuation of a CNI-based regimen
干预措施: cyclosporine or tacrolimus (Drug)
结局指标
主要结局
New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year
时间窗: up to 24 months
The number of new biopsy-confirmed NMSC lesions per subject per year was calculated by summarizing the total number of new BCC and SCC lesions reported over the observation period and standardizing it to an annual rate by multiplying by 365 and dividing by days on study.
次要结局
- Time to First Biopsy Confirmed New NMSC Lesion.(up to 24 months)
- Number of Lesion Free Subjects(up to 24 months)
- Percentage of Patients With New Biopsy-confirmed NMSC: Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC)(up to 24 months)
- Grade Distribution of NMSC Lesions(up to 24 months)
- Number of Recurrent NMSC Lesions Per Subject-year(up to 24 months)
- Subjects Reporting Incidence of Metastatic Disease Related to NMSC.(up to 24 months)
- Death Due to NMSC(up to 24 months)
- Number of Subjects Who Discontinue Assigned Therapy(up to 24 months)
- Nankivell-Calculated Glomerular Filtration Rate (GFR)(At 24 months (week 104))
- Serum Creatinine Level(At 24 months (Week 104))
- Number of Participants That Died(up to 24 months)
- Graft Survival Measured by Graft Loss(up to 24 months)
- Number of Subjects With Biopsy-Confirmed Acute Rejection(up to 24 months)
- Spot Urine Protein:Creatinine Ratio(At 24 months (Week 104))
研究者
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