NCT00159159Unknown4 期
LOW CYCLO: A Multicenter, Prospective, Randomized Study Evaluating the Benefit, on Renal Function, of Two Doses of Ciclosporine: Low Dose Versus Usual Dose, in Association With Mycophenolate and Corticoïds, in de Novo Cardiac Transplant
适应症
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Evolution of renal function, as assessed by the evolution between the two treatment groups at 12 months versus baseline serum creatinine level
研究概览
简要总结
Primary Objective:
- Evaluation of the benefit on renal function of one year of a low dose of ciclosporine versus the usual dose
Secondary Objective:
- To evaluate the immunosuppressive efficacy and tolerance of the treatment
Study Duration:
Twelve months for each patient
Study Treatment: Ciclosporine
Group A: low dose >= 130 µg/l < T0 ciclosporinemia < 200 µg/l; Group B: standard dose >= 200 µg/l < T0 ciclosporinemia < 300 µg/l.
Study Visits:
One visit every 15 days, for the first three months; then 1 visit every month, for 6 months; and 1 visit at 9 and 12 months.
Associated Treatments:
- Mycophenolate (Cellcept®), 3g a day
- Corticoids, as used for transplanted patients
Randomization: Randomization will occur when it is decided that ciclosporine will be introduced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, ages > 18 <
- •First cardiac transplant.
- •Negative pregnancy test for females of childbearing potential, at screening. Efficient method of contraception must be used during the study.
- •Written informed consent.
- •Cold ischemia duration < 6 hours
排除标准
- •Unstable hemodynamic status at randomization.
- •Patient with assisted circulation, considered unstable.
- •Serum creatinine > 250 µmol/l.
- •Nursing or pregnant females.
- •HIV positive.
- •PCR hepatitis C virus (HCV) positive or hepatitis B surface (Hbs) antigen positive (within 6 months prior to study).
- •Multi-organ graft or retransplant.
- •History of cancer (evolving, or within 5 years, except for epidermoid or basocellular localised cutaneous carcinoma).
- •Use of any investigational product and/or participation in another clinical research study within the last 30 days prior to study entry.
- •Any substance abuse or any psychiatric disorder
- •Contra-indication to study treatments.
- •Unable to introduce ciclosporine within 4 days after transplant.
- •Known coronary pathology or cardiac disease.
- •HBsAg positive or HCV positive
结局指标
主要结局
Evolution of renal function, as assessed by the evolution between the two treatment groups at 12 months versus baseline serum creatinine level
次要结局
- Area under curve of creatinine at 12 months
- Cystatin C level at 1, 2, 3, 6 and 12 months
- Creatinine clearance at 6 and 12 months
- Proteinuria and microalbuminuria at 6 and 12 months
- Secondary outcomes include those linked to the immunosuppressive efficacy and tolerance of the treatment: Difference in appearance incidence of acute graft reject and adverse events
- Myocardial biopsy (International Society of Heart and Lung Transplantation [ISHLT] grades)
- Difference in the evolution of left ventricular function and cardiovascular risk factors between the two groups at 6 and 12 months versus baseline: left ventricular ejection fraction and shortening fraction (echocardiogram)
- systolic and diastolic blood pressure
- fasting glycemia, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides
研究者
研究点 (1)
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