临床试验/NCT00239798

NCT00239798已完成2 期

A 24-month Extension of a One-year, Multicenter, Double Blinded Double Dummy, Randomized Study to Evaluate the Safety and Efficacy of Two Doses of FTY720 Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Steroids Versus Mycophenolate Mofetil Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Steroids, in Adult de Novo Renal Transplant Recipients

Novartis Pharmaceuticals0 个研究点目标入组 255 人开始时间: 2004年11月1日最近更新: 2017年2月23日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Novartis Pharmaceuticals
入组人数: 255
主要终点: IA, IB, IIA, IIB, III, or humoral acute rejection diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.

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: Double

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients who have completed the 12 Month visit of the Core trial either on or off study drug.
•Female capable of becoming pregnant are required to have a medically approved method of birth control until 3 Month after study medication was stopped.

排除标准

未提供

结局指标

主要结局

IA, IB, IIA, IIB, III, or humoral acute rejection diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant

Permanent resumption of dialysis within 36 months post transplant

Surgical removal of graft within 36 months post transplant

Death within 36 months post transplant

Withdrawal of consent, death, or lost to follow up within 36 months post transplant

Serum creatinine, and estimated creatinine clearance within 36 months post transplant

FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% within 36 months post transplant

Absolute lymphocyte count within 36 months post transplant

次要结局

Withdrawal of consent, death, or lost to follow up at Month 24 and Month 36 post-transplant
IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria at Month 24 and Month 36 post-transplant
Permanent resumption of dialysis at Month 24 and Month 36 post-transplant
Surgical removal of graft at Month 24 and Month 36 post-transplant
Death at Month 24 and Month 36 post-transplant
Serum creatinine, and estimated creatinine clearance at Month 24 and Month 36 post-transplant
FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Month 24 and Month 36 post-transplant
Absolute lymphocyte count at Month 18, 24, 30 and 36

研究者

发起方

Novartis Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

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