NCT00150085终止4 期
A Prospective, Randomized, Open-label, Twenty-six Week Study of the Efficacy and Safety of Converting Kidney and Liver Transplant Recipients With Tacrolimus-associated Abnormal Glucose Metabolism to Cyclosporine Micro-emulsion With C2 Monitoring
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Novartis
- 入组人数
- 50
- 主要终点
- Proportion of patients who no longer require a hypoglycemic agent, or who move from insulin to an oral agent, or who no longer meet the American Diabetes Association criteria, or a relative improvement in mean glycosylated hemoglobin at 12 and 26 weeks
研究概览
简要总结
New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM. This study evaluates the safety and efficacy of converting patients with NODM from tacrolimus to cyclosporine micro-emulsion as a primary immunosuppressant for kidney and liver recipients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipients of first or second cadaveric or living donor kidney transplantation or first cadaveric or living donor liver transplantation
- •Receiving tacrolimus as a primary immunosuppressant
- •Currently on any diabetic agent or meets the American Diabetes Association definition of diabetes mellitus
排除标准
- •History of treated diabetes mellitus prior to transplantation
- •Less than 2 weeks post-transplantation for kidney and less than 8 weeks for liver
- •Greater than 36 months post-transplantation
- •Onset of diabetes is greater than 12 months prior to time of study entry
- •Has unacceptable or unstable graft function
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Proportion of patients who no longer require a hypoglycemic agent, or who move from insulin to an oral agent, or who no longer meet the American Diabetes Association criteria, or a relative improvement in mean glycosylated hemoglobin at 12 and 26 weeks
次要结局
- Safety assessed by death, graft loss, biopsy supported clinically manifested acute rejection, change in kidney function, change in liver function, serious adverse events and adverse events at 12 and 26 weeks
研究者
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