Reduction or Discontinuation of Calcineurine Inhibitors With Conversion to Everolimus-Based Immunosuppresion to Alleviate Chronic Allograft Nephropathy (CAN) in Kidney Transplant Recipients: A Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The primary goal is to assess the change in renal function
研究概览
简要总结
This study is design to compare two different strategies aiming to lessen the degree of the ongoing process of allograft injury either by removing tacrolimus from the maintenance immunosuppressive protocol or by reducing tacrolimus dose.
The primary goal is to assess the change in renal function at 6 and 12 months after conversion using creatinine levels and calculated creatinine clearance.
The study will include two groups: The study group of 30 patients and a matched control group with creatinine levels at similar range.
详细描述
This study is design to compare two different strategies aiming to lessen the degree of the ongoing process of allograft injury either by removing tacrolimus from the maintenance immunosuppressive protocol or by reducing tacrolimus dose.
The primary goal is to assess the change in renal function at 6 and 12 months after conversion using creatinine levels and calculated creatinine clearance.
The study will include two groups: The study group of 30 patients and a matched control group with creatinine levels at similar range.
Patients will undergo the following baseline studies:
- Doppler ultrasound to exclude any mechanical or a vascular problem.
- A kidney biopsy to define the histological changes (degree of interstitial fibrosis, tubular and glomerular changes). The biopsies will be stained also for C4D and for fibrinogenic markers (TGF-beta, and collagen).
- A 24-hour urine protein excretion and creatinine clearance
- Echocardiography study
- Carotid Ultrasound
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients on CNI FK < 5 ng/m"l with MPA / Imuran with or without steroids
- •Renal impairment GFR between 30 - 70 m"l/minute/
- •Patient who signed Informed consent
- •Patient with no contraindication to renal biopsy
- •Women who are not pregnant and will use contraception
排除标准
- •Proteinuria > 100 m"g/mmol Creatinine
- •Acute rejection during 3 months before screening
- •WBC < 2500, plt < 50,000,
- •Nephropathy due to polyoma virus
- •Patients on other investigational drugs
- •Patients on rapamycin
- •Patients with HIV or other systemic infection
- •Inability to comply with protocol requirements
- •Active or history of malignancy
结局指标
主要结局
The primary goal is to assess the change in renal function
at 6 and 12 months after conversion using creatinine levels
and calculated creatinine clearance.
次要结局
- The secondary aim is to assess changes in cardiovascular risks at
- 12 months after conversion (glucose control., cholesterol and
- triglyceride levels and hypertension control), incidence of
- acute and chronic rejection and graft and patient survival rates.