A Randomized, Open-label Study to Compare the Safety and Efficacy of Cyclosporine Dose Reduction With Cyclosporine Elimination in De Novo Renal Allograft Recipients Receiving Rapamune.

Wyeth is now a wholly owned subsidiary of Pfizer13 个研究点分布在 2 个国家目标入组 280 人开始时间: 2004年3月1日最近更新: 2011年3月8日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 280
试验地点: 13
主要终点: Calculated creatinine clearance at 12 months post transplantation for patients on therapy.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Group I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Group II).

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Subjects with end-stage renal disease scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or a living-related HLA-mismatched donor. Subjects must be at least 18 years of age.

排除标准

•Subjects with active major infection, including active hepatitis B or C infection, decreased platelets, elevated lipids, or multiple organ transplants.

结局指标

主要结局

Calculated creatinine clearance at 12 months post transplantation for patients on therapy.

次要结局

Calculated creatinine clearance at 6 months Serum creatinine at 6 and 12 months post-transplantation. Graft survival at 6 and 12 months post-transplantation. Incidence of biopsy confirmed acute graft rejections at 6 and 12 months post transplantation.

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

研究点 (13)

Loading locations...

相似试验

已完成

3 期

Study Evaluating Sirolimus in Kidney Transplant Recipients.Kidney FailureGraft vs Host Disease

NCT00167947Wyeth is now a wholly owned subsidiary of Pfizer150

已完成

4 期

Study Comparing Graft Function in Renal Allograft Recepients Receiving Reduced or Standard Dose CsA With SirolimusKidney Transplantation

NCT00518375Wyeth is now a wholly owned subsidiary of Pfizer250

已完成

1 期

Validation of Serum Creatinine Dosage and Renal ClearanceKidney Failure

NCT00323128University Hospital, Ghent30

已完成

4 期

Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant PatientsKidney Transplantation

NCT00519116Wyeth is now a wholly owned subsidiary of Pfizer150

已完成

3 期

Study Evaluating Sirolimus in Kidney Transplant RecipientsGraft vs Host DiseaseKidney Transplantation

NCT00195273Wyeth is now a wholly owned subsidiary of Pfizer61