Conversion Study to Optimize Immunosuppressive Regimen by Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction for Patients After Heart Transplantation in Lon-Term
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Renal function evaluated by serum creatinine at month 12 and month 24
研究概览
简要总结
The purpose of this study is to improve or save renal function by optimizing the immunosuppressive regimen by reducing the Cyclosporine A dose and the exchange of Azathioprine by Mycophenolatmofetile, which is an effective immunosuppressive agent and will minimize the risk of acute rejection episodes.
详细描述
The decrease of quality of life in patients after heart transplantation in the long-term is determined by an increasing incidence of transplant vasculopathy and by immunosuppression-related side effects.Long-term administration of calcineurin inhibitors is associated with chronic nephrotoxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current immunosuppressive regimen: Cyclosporine A, Azathioprine and corticosteroids for at least 12 month
- •Heart transplantation above 3 years dated back
- •Serum creatinine < 3,5 mg/dl (310 µmol/l) and BUN < 150 mg/dl
- •Cyclosporine A blood level between 50 and 250 ng/ml during the last 12 month
排除标准
- •Carcinoma within the last 3 years
- •Acute rejection episodes during the last 6 month
- •Infection requiring therapeutic intervention
- •Hepatitis B, Hepatitis C or HIV infection
- •WBC < 3000/µl, haemoglobin < 9g/dl, platelets < 70.000/µl
- •Florid gastrointestinal ulcer
- •Haemodialysis within the last 4 weeks before study entry
- •Pregnancy / lactation
- •Administration of other immunosuppressive agents than prescribed
- •Mycophenolatmofetile incompatibility
研究组 & 干预措施
1
Azathioprine administration: was stopped at day 0; Mycophenolatmofetile administration: was started with 250 mg/daily at day 1, the start dose was increased about 250 mg/daily every week till 2 g/daily; Cyclosporin A reduction: Cyclosporin A trough level reduction started after week 8. The new target range was 50 to 90 ng/ml
干预措施: Mycophenolatmofetile (Drug)
1
Azathioprine administration: was stopped at day 0; Mycophenolatmofetile administration: was started with 250 mg/daily at day 1, the start dose was increased about 250 mg/daily every week till 2 g/daily; Cyclosporin A reduction: Cyclosporin A trough level reduction started after week 8. The new target range was 50 to 90 ng/ml
干预措施: Cyclosporin A (Drug)
结局指标
主要结局
Renal function evaluated by serum creatinine at month 12 and month 24
时间窗: month 12 and month 24
次要结局
- acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24(month 12 and month 24)
- Cardiovascular risk factors at month 12 and month 24(month 12 and month 24)
- Quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24(month 12 and month 24)