A One-year, Open Label Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients.

Novartis0 个研究点目标入组 20 人开始时间: 2004年1月1日最近更新: 2017年2月23日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Novartis
入组人数: 20
主要终点: Graft function 6 months post transplantation

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

The study is a one-year prospective, open-label, safety and efficacy study. De novo renal transplant recipients will be receiving cyclosporine, 1.44g EC-MPS (720 mg b.i.d.), and corticosteroids .The study will consist of a 12-month open-label treatment period on EC-MPS.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Prevention
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

•Males and females aged 18-75 years. Recipients of de novo cadaveric, living unrelated or living related kidney transplants

排除标准

•Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ.
•Patients who are recipients of A-B-O incompatible transplants. Patients with a historical or current peak PRA of 50%. Patients with already existing antibodies against the HLA-type of the receiving transplant.
•Evidence of severe liver disease (incl. abnormal liver profile i.e. AST, ALT or total bilirubin 3 times UNL).
•Patients who are HIV or Hepatitis B surface antigen positive. Patients with any known hypersensitivity to mycophenolic acid, MMF, EC-MPS, other components of the formulation (e.g. lactose).
•Patients with thrombocytopenia (75,000/mm3), with an absolute neutrophil count of < 1,500/mm3, and/or leukocytopenia (< 2,500/mm3), and/or hemoglobin < 6 g/dL at Screening or Baseline.
•Other protocol-defined inclusion/exclusion criteria may apply.

结局指标

主要结局

Graft function 6 months post transplantation

次要结局

Incidence of biopsy proven acute rejection, graft loss or death within 6 and 12 months post transplantation
Incidence of biopsy proven acute rejection within 6 and 12 months post transplantation
Time to first biopsy-proven acute rejection
Graft survival and patient survival at 6 and 12 months
Severity of biopsy-proven acute rejection

研究者

发起方

Novartis

申办方类型

Industry

相似试验

已完成

4 期

Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant RecipientsKidney Transplantation

NCT00170885Novartis

招募中

1 期

Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC in AIS-A Level of Sub-acute SCISpinal Cord Injury, AcuteSpinal Cord Injury at C4 Level With Complete LesionSpinal Cord Injury at C5-C7 Level With Complete Lesion

NCT04812431S.Biomedics Co., Ltd.5

Unknown

1 期

Study of ASC-101 in Patients With Hematologic Malignancies Who Receive Dual-cord Umbilical Cord Blood TransplantationBlood And Marrow TransplantationTransplantation InfectionMyelodysplastic Syndrome (MDS)Non-Hodgkin's Lymphoma (NHL)Hodgkin's LymphomaLymphomaLeukemia

NCT01983761Targazyme, Inc.25

Unknown

2 期

Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression ControlHypertensionAutosomal Dominant Polycystic Kidney Disease

NCT01932450Mei changlin100

已完成

4 期

Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant RecipientsRenal Transplantation

NCT00238953Novartis30