A Twelve-month, Randomized, Multicenter, Open-label, Exploratory Study to Investigate the Clinical Outcomes of an Immunosuppressive Regimen of Basiliximab, Cyclosporine Microemulsion (CsA-ME) and Enteric-coated Mycophenolate Sodium (EC-MPS) Free of Steroids Compared With a Regimen of EC-MPS With Standard Steroids in de Novo Kidney Recipients Who Are Hepatitis C Positive

Novartis Pharmaceuticals0 个研究点目标入组 60 人开始时间: 2004年4月1日最近更新: 2011年11月2日

适应症

试验速览

阶段: 3 期
状态: 终止
发起方: Novartis Pharmaceuticals
入组人数: 60
主要终点: Hepatic function tests (ALT/AST) after 12 months treatment.

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

To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard steroids, as measured by the hepatic function tests (ALT/AST) after 12 months treatment.

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

入选标准

•Patients hepatitis C positive (serology test within the last 12 months and determined by third-generation assay).
•Recipients of heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with basiliximab and CsA-ME as primary immunosuppression.

排除标准

•Multi-organ recipients (e.g. double kidney, kidney and pancreas or kidney and liver) or previous transplant with any other organ.
•Kidneys from non-heart beating donors.
•ABO incompatibility against the donor.
•Patients with panel reactive antibodies of >50% at most recent assessment prior to transplantation and /or prior graft lost due to immunological reasons in the first six months post-transplantation or patients who are considered to be at increased risk of acute rejection by the principal investigator Additional protocol defined inclusion/exclusion criteria may apply.

结局指标

主要结局

Hepatic function tests (ALT/AST) after 12 months treatment.

次要结局

Acumulative incidence of biopsy proven acute rejection after 3 and 12 months.
Graft loss, biopsy-proven acute rejection after 3 and 12 months treatment.
Glomerular filtration rate and by proteinuria after 12 months treatment.
Graft survival after 12 months.
Incidence of AEs and SAEs after 3 and 12 months.
Blood pressure, lipids and glucose profiles after 3 and 12 months.
Percentage of patients free of steroids at 12 months between the two investigational groups.
Viral load (HCV RNA) between both groups at 12 months.
Bone density at 12 months in both groups.

研究者

发起方

Novartis Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

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