A Single-center,Randomized,Open-label,12 Months Study,2 Parallel Group to Compare the Efficacy of Everolimus Combination + Tacrolimus in Regression of Left Ventricular Hypertrophy vs Tacrolimus + MMF in Renal Transplant Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction of Left Ventricular Hypertrophy
研究概览
简要总结
Clinical study with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase.
详细描述
A single-center, randomized, open-label, 12 months study, with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase.
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
- •Patient's signed informed consent prior to any study-related procedure.
- •Adult patients (> 18 years), renal transplant recipients of more than 1 year of evolution.
- •Patients receiving maintenance immunosuppression with tacrolimus delayed release (Envarsus®) and MMF / MPA.
- •Patients with Left Ventricular Hypertrophy detected by Cardio-NMR.
- •Subjects with glomerular filtration rate >30 ml/min (calculated by CKD-EPI) and stable in the last two analytical determinations (variation <20%).
- •No known contraindications to the use of Mtor inhibitors (previous intolerance, deep vein thrombosis , pulmonary embolism, proteinuria > 0.5 g/day)
- •Patients with Hb levels ≥ 11 gr/dl.
- •Patients with blood pressure <140/90 mmHg in the hospital visits or <135/85 mmHg at home.
排除标准
- •Patient's signed informed consent prior to any study-related procedure.
- •Adult patients (> 18 years), renal transplant recipients of more than 1 year of evolution.
- •Patients receiving maintenance immunosuppression with tacrolimus delayed release (Envarsus®) and MMF / MPA.
- •Patients with Left Ventricular Hypertrophy detected by Cardio-NMR.
- •Subjects with glomerular filtration rate >30 ml/min (calculated by CKD-EPI) and stable in the last two analytical determinations (variation <20%).
- •No known contraindications to the use of Mtor inhibitors (previous intolerance, deep vein thrombosis , pulmonary embolism, proteinuria > 0.5 g/day)
- •Patients with Hb levels ≥ 11 gr/dl.
- •Patients with blood pressure <140/90 mmHg in the hospital visits or <135/85 mmHg at home.
研究组 & 干预措施
Everolimus arm
Patients will be converted from Tacrolimus + Mycophenolate mofetil to Everolimus + Tacrolimus 'Conversion from Mycophenolate mofetil to Everolimus'
干预措施: Everolimus (Drug)
Everolimus arm
Patients will be converted from Tacrolimus + Mycophenolate mofetil to Everolimus + Tacrolimus 'Conversion from Mycophenolate mofetil to Everolimus'
干预措施: Tacrolimus (Drug)
Mycophenolate arm
Patients will remain in Tacrolimus + Mycophenolate mofetil combination
干预措施: Mycophenolate mofetil (Drug)
Mycophenolate arm
Patients will remain in Tacrolimus + Mycophenolate mofetil combination
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Reduction of Left Ventricular Hypertrophy
时间窗: 12 months
Reduction of Left Ventricular Hypertrophy more or equal than 10 g/m2 in the study group compared to control group at 12 months. Regression of LVH is defined as a decrease of 10 g/m2 compared to baseline value. Cardio nuclear magnetic resonance will be performed to evaluate left ventricular hypertrophy
次要结局
未报告次要终点
研究者
Edoardo Melilli
Principal Investigator MD
Hospital Universitari de Bellvitge