NCT00510913已完成4 期
Prograf® (Tacrolimus) as Secondary Intervention vs. Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 18
- 主要终点
- Graft Survival
研究概览
简要总结
A study to compare the conversion to Prograf® (tacrolimus) to the continuation of cyclosporine in patients at risk for chronic renal allograft failure
详细描述
A two arm study (1 Active, 1 Active control) to compare the incidence, progression and severity of chronic renal allograft failure in at-risk patients who are converted from cyclosporine-based to tacrolimus-based immunosuppression to patients who remain on cyclosporine-based therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been on cyclosporine-based immunosuppression regimen since the transplant
- •Patient has at least one pre-defined risk factor for chronic allograft failure
排除标准
- •Patient is dialysis dependent
- •Patient is recipient of a solid organ transplant other than the kidney
结局指标
主要结局
Graft Survival
时间窗: 5 years
次要结局
- Patient survival, Graft Loss(5 years)
研究者
研究点 (18)
Loading locations...
相似试验
已完成
4 期
Tacrolimus as Secondary Intervention vs. Continuation of Cyclosporine in Renal Transplant Patients With Chronic Renal Allograft Failure (CRAF)Renal TransplantationChronic Renal Allograft FailureNCT00637143Astellas Pharma Inc107
已完成
2 期
Conversion of Prograf to Advagraf in Pediatric Renal Transplant RecipientsKidney TransplantationPediatric PatientsMaintenance With TacrolimusNCT01476488Seoul National University Hospital
已完成
4 期
Pharmacokinetic Studies of Tacrolimus in Transplant PatientsKidney Transplant RecipientsLiver Transplant RecipientsNCT01889758University of Cincinnati78
已完成
4 期
Tacrolimus Versus Prednisolone for the Treatment of Minimal Change DiseaseMinimal Change DiseaseNCT00982072Imperial College Healthcare NHS Trust52
已完成
4 期
Study to Assess the Safety and Efficacy of Tacrolimus (Prograf Capsule/Injection) and Methotrexate (MTX) Combination Therapy for Prevention of Graft Versus Host Disease (GVHD) in Patients Who Received Peripheral Hematopoietic Stem Cell Transplantation From a Sibling DonorGraft Versus Host DiseaseNCT02660684Astellas Pharma Korea, Inc.39