KCT0000602已完成未知
An open-label, two-center study evaluating the safety and efficacy of converting from calcineurin inhibitors to sirolimus in renal allograft recipients with mild to moderate renal insufficiency
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Age over 18 years
- •- Patients who administered CNI at least over 3 months
- •- GFR(Cockcroft-Gault) over 40mL/min and proteinuria under 300mg/day
- •- Mild and moderate renal insufficiency with stable renal function (variable range of serum creatinine maintained within 20% during 1 month before study enrollment)
- •- Negative pregnancy test
排除标准
- •1. Pancreas transplantation patients
- •2. Patients who recieved acute rejection treatment within 3 months before registration of this clinical trial
- •3. Genral or local infection at the screening time
- •4. Evidence of infiltration, cavitation, or consolidation in chest X-ray at the screening course
- •5. Unstable angina, threatened arrhythmia that need to be treated
- •6. Malignancy or PTLD diagnosed within 5 years before registration
- •7. Administration of other clinical trial medication within 4 weeks before registration
- •8. Administration of below medicine that affect pharamodynamic of sirolimus: terfenadine, cisapride, astemizole, pimozide, ketoconazole, voriconazole, fluconazole
- •9. Continuous administration of medicine that affect renal fuction (i.e, aminoglycoside, amphotericin B, cisplatin, etc)
- •10. Allergic reaction to sirolimus or derivatives from sirolimus
- •11. WBC count = 3,000/mm3, Platelet = 100,000/ mm3, fasting triglyceride = 400mg/dL, fasting cholesterol = 300mg/dL, fasting HDL-c = 30mg/dL, fasting LDL-c = 200mg/dL
- •12. Known active B-viral or C-viral hepatitis
- •13. Known HIV positive patients
- •14. Pregnant or lactating women
- •15. Continuing dialysis for more than 8 weeks
- •16. Patients who underwent major operation within 4 weeks before regisration
研究者
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