EUCTR2006-002420-41-ES进行中（未招募）1 期
Estudio aleatorizado y abierto, comparativo de la seguridad y la eficacia del cambio de un inhibidor de la calcineurina a sirolimus frente a la continuación del uso de un inhibidor de la calcineurina en trasplantados cardiacos con insuficiencia renal de grado leve a moderado A Randomized, Open-Label Study to Compare the Safety and Efficacy of ConversionFrom a Calcineurin Inhibitor to Sirolimus Versus Continued Use of a CalcineurinInhibitor in Cardiac Transplant Recipients With Mild to Moderate Renal Insufficiency
Wyeth Research, Division of Wyeth Pharmaceuticals, Inc.0 个研究点目标入组 200 人开始时间: 2010年3月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Cardiac transplant recipients aged greater than/equal to 18 years.
- •2.Receiving CsA or TAC as part of the maintenance immunosuppressive regimen since the time of transplantation.
- •3.12 Months after cardiac transplantation but equal to or less than 96 months after transplantation at the time of screening.
- •4.GFR > 40 mL/min but < 90 mL/min/1,73m2 (calculated by the Cockcroft-Gault equation and adjusted for bosy surface area [BSA] using the Mosteller formula) with stable renal function (as defined by no decrease > 20% of GFR) over the previous 3 months.
- •5.Left ventricular ejection fraction by echocardiogram (ECHO) greater than/equal to 40%.
- •6.Women of childbearing potential (CBP) must have a negative urine pregnancy test before randomization.
- •7.Women of CBP and men with sexual partners of CBP must agree to use a medically acceptable method of contraception throughout the treatment period.
- •8.Women of CBP and men with sexual partners of CBP must agree to use a medically acceptable method of contraception for 3 months after discontinuation of assigned treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Secondary cardiac transplant recipients (subjects who have lost 1 or more previous cardiac transplant).
- •2.Multiple-organ transplant recipients (such as heart-lung, heart-kidney, or heart-after-kidney transplant recipients).
- •3.Treatment of acute rejection within 3 months.
- •4.Evidence of active systemic or localized major infection at the time of randomization.
- •5.Evidence of infiltrate, cavitation or consolidation on chest x-ray film obtained within 3 months before or at the time of the screening evaluation.
- •6.Use of any investigational drug or treatment up to 4 weeks before random assignment.
- •7.Spot urine protein-to-creatinine ratio > 0.5 or proteinuria > 500 mg/day.
- •8.Subjects maintained on CNI monotherapy.
- •9.Prior or current use of mammalian target of rapamycin (mTOR) inhibitors unless administration was part of a CNI holiday (a planned temporary switch from a CNI to an mTOR inhibitor to limit exposure to CNIs) lasting no more than 10 days.
- •10.Known hypersensitivity to sirolimus or its derivatives or macrolide antibiotics.
- •11.Treatment with voriconazole, cisapride, or ketoconazole, which are all known to interact with sirolimus, that is not discontinued before randomization.
- •12.Treatment with aminoglycosides, amphotericin B, cisplatin, or other drugs associated with renal dysfunction that is not discontinued before randomization.
- •13.Subjects with screening baseline white blood cell (WBC) count < 3000/mm3, platelet count < 100,000/mm3, fasting triglyceride level > 400 mg/dL (4.5 mmol/L), or total cholesterol level > 300 mg/dL (7.6 mmol/L).
- •14.History of malignancy within 3 years before enrollment (except for adequately treated basal-cell or squamous-ell carcinoma of the skin).
- •15.Planned used of agents with a known major interaction with sirolimus or CNIs.
- •16.Subjects who are known to be positive for human immunodeficiency virus (HIV).
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