NCT00308425已完成3 期
Effect of Enteric-Coated Mycophenolate Sodium (EC-MPS) Plus Valsartan as Part of Intensified Multi-factorial Intervention Compared to EC-MPS Plus Standard Practice of Care on Development of Transplant Nephropathy in Cadaver Donor Kidney Recipients Given Basiliximab, Cyclosporine Microemulsion (CsA-ME) and Short-term Steroids: a 12-month, Prospective, Randomized, Open-label Multicentre Study (MYTHOS)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 119
- 主要终点
- 12-month rate of success in preventing relapse of nephropathy, defined as persistent albumin excretion rate (AER) > 300 mg/24h and safety, compared between groups.
研究概览
简要总结
The primary aim of this study is to evaluate the safety and efficacy of EC-MPS plus valsartan as part of an intensified multifactorial intervention on the reduction of the 12-month rate of transplant nephropathy compared with EC-MPS plus standard practice of care in recipients of a first cadaver donor kidney transplant given CsA-ME, basiliximab, and short-term steroids.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Male and female patients aged 18 to 70 years
- •Patients receiving a first kidney transplant from a cadaver donor, who are scheduled to receive CsA-ME and anti-CD25 antibody as primary immunosuppression;
- •Patients able to receive the first dose of EC-MPS within 48 hours of graft reperfusion
排除标准
- •Multi-organ recipients (e.g. kidney and pancreas, double kidney) or previous transplant with any other organ.
- •Recipient of a kidney from a non-heart beating, from a cadaver donor aged more than 70 years, or with cold ischemia time of more than 36 hours
- •Recipient who is HLA-identical to the donor
- •Patients with a PRA level (past or current level) higher than 50%
- •Patients with a known hypersensitivity to EC-MPS or 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.
- •HIV-positive
- •Positive HBsAg test for both donor and recipients.
- •Unstable angina, acute myocardial infarction or stroke during the last 6 month or heart failure NYHA class III-IV or hemodinamically significant valvular heart disease
- •Liver injury as indicated by transaminase serum levels (ALT and/or AST) greater than 2 x ULN
- •Creatinine kinase (CK) levels greater than 5 x ULN. Additional protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
12-month rate of success in preventing relapse of nephropathy, defined as persistent albumin excretion rate (AER) > 300 mg/24h and safety, compared between groups.
次要结局
- Renal function, as measured by serum creatinine and calculated creatinine clearance after 6 and 12 months;
- Glomerular filtration rate (GFR), as plasma clearance of unlabeled iohexol, after 6 and 12 months;
- Albumin excretion rate and fractional clearance of albumin after 6 and 12 months;
- Fasting blood glucose levels, total cholesterol, triglyceride and HDL levels and systolic and diastolic blood pressure after 6 and 12 months;
- Incidence of acute rejection after 6 and 12 months;
- Patient and graft survival at 12 months;
研究者
相似试验
已完成
4 期
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion Based Regimen in de Novo Living Donor Kidney Transplant RecipientsKidney TransplantNCT00537862Novartis Pharmaceuticals200
已完成
3 期
Study of Enteric-coated Mycophenolate Sodium Maintenance Therapy in Patients With Renal Transplant Receiving Cyclosporine Microemulsion and Steroids,Maintenance Renal TransplantationNCT00239057Novartis23
已完成
2 期
Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis FlareLupus NephritisNCT00423098Novartis Pharmaceuticals81
已完成
3 期
Study of Enteric-coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult de Novo Renal Transplant PatientsRenal TransplantNCT00149903Novartis Pharmaceuticals300
已完成
4 期
Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant PatientsKidney TransplantationNCT00239083Novartis40