A Randomized Open-Label Study To Compare The Safety And Efficacy Of Conversion From A Calcineurin Inhibitor To Sirolimus Vs Continued Use Of A Calcineurin Inhibitor In Heart Transplant Recipients With Mild-Moderate Impaired Renal Function
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 52 Weeks Post-randomization
研究概览
简要总结
The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal function in cardiac transplant recipients with mild to moderate renal dysfunction.
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
- •Cardiac transplant recipients age 18 years or older receiving cyclosporine or tacrolimus since the time of transplant.
- •12 months after cardiac transplantation but less than 96 months post-transplantation.
排除标准
- •Multiple-organ transplant recipients (such as heart-lung, heart-kidney, or heart after kidney transplant recipients).
- •Prior or current use of sirolimus or everolimus unless administration was part of a "CNI holiday" lasting no more than 10 days.
- •History of acute rejection within the last 3 months, malignancy within the last 5 years (except for adequately treated basal cell or squamous cell carcinoma of the skin), and human immunodeficiency virus (HIV) patients.
研究组 & 干预措施
1
Group 1: Continuation of CNI regimen
干预措施: cyclosporine or tacrolimus (Drug)
2
Group 2: (CNI-Free) Conversion to SRL-based regimen
干预措施: sirolimus (Drug)
结局指标
主要结局
Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 52 Weeks Post-randomization
时间窗: Baseline and Week 52
Creatinine Clearance (CC) calculated using Cockcroft-Gault equation, adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is greater than or equal to (≥) 90 milliliters per minute per 1.73 meters squared (mL/min/1.73m\^2). Change from baseline=CC at Week 52 minus CC at baseline where higher scores represented improved renal function; Least squares mean adjusted for baseline calculated creatinine clearance and center.
Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Baseline
时间窗: Baseline
Creatinine clearance at baseline calculated using Cockcroft-Gault equation and adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m\^2.
次要结局
- Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 4, 16, 24, 32, and 40 Weeks Post-randomization(Baseline and Weeks 4, 16, 24, 32, and 40)
- Change From Baseline in Calculated Creatinine Clearance (Modification of Diet in Renal Disease [MDRD] Equation) at 4, 16, 24, 32, 40 and 52 Weeks Post-randomization(Baseline and Weeks 4, 16, 24, 32, 40 and 52)
- Calculated Creatinine Clearance (Modification of Diet in Renal Disease [MDRD] Equation) at Baseline(Baseline)
- Change From Baseline in Serum Creatinine Level at 4, 16, 24, 32, 40, and 52 Weeks Post-randomization(Baseline and Weeks 4, 16, 24, 32, 40, and 52)
- Serum Creatinine Level at Baseline(Baseline)
- Annual Change in Calculated Creatinine Clearance (Cockcroft-Gault Equation)(Baseline to discontinuation (up to Week 52))
- Overall Survival (OS)(Baseline until death (up to Week 56))
- Number of Participants With Acute Rejection(Baseline to Week 52)
- Number of Participants With Biopsy-confirmed Acute Rejection by Severity(Baseline to Week 52)
- Time to First Acute Rejection(Baseline to Week 52)
- Number of Participants Requiring Antibody Use in Treatment of Acute Rejection(Baseline to Week 52)
- Number of Participants in Sirolimus Treatment Group Requiring Conversion Back to CNI Therapy(Baseline up to Week 52)