NCT00239057已完成3 期
Enteric-Coated Mycophenolate Sodium (EC-MPS) Administration in Maintenance Renal Transplant Patients Receiving Cyclosporine Microemulsion (CsA-ME) and Steroids, for the Withdrawal of Concomitant Steroid Therapy: a Prospective, Open-label, Exploratory Study
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
- 23
- 主要终点
- Incidence of biopsy prove acute rejection requiring treatment within six months of the start of the study.
研究概览
简要总结
The aim of this study is to evaluate if the addition of EC-MPS to CsA-ME allows the safe withdrawal of the concomitant corticosteroid therapy in long-term maintenance renal allograft recipients.
All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Male or female, 18 years of age or older.
- •Recipients of first or secondary cadaver, living related or unrelated donor kidney transplant performed at least 6 month before screening (Visit 1)
- •Patients currently receiving CsA-ME and corticosteroids (at least 5 mg of prednisone equivalents) for at least 3 months prior to Screening, with or without Mycophenolate mofetil or azathioprine.
- •4. Serum creatinine levels < 2.3 mg/dL (=204 µmol/L) at screening and at baseline
- •Stable kidney function, i.e. increase in serum creatinine less than 20% in the last 3 months before screening and at baseline (baseline value as compared to the value obtained at screening)
排除标准
- •Multi-organ recipients (e.g., kidney and pancreas, double kidneys) or previous transplant with any other organ different from kidney
- •Patients whit a second transplant who rejected the first one for immunological reasons or because of the relapse of the autoimmune disease which leaded to the end-stage renal failure
- •Histological evidence of acute rejection or treatment for acute rejection within the three months prior to Screening, or histological signs or clinical signs of chronic rejection (as significant proteinuria, i.e. > 300 mg/24 hours.
- •Patients with maintenance steroid therapy for other diseases (i.e. autoimmune diseases, Lupus).
- •Patients with any 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 (<4,000/mm3), and/or anemia (hemoglobin <9.0 g/dL) prior to Screening visit.
- •Patients who have received an investigational drug within two weeks prior to Screening visit.
- •Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
- •Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
- •Presence of clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus that would interfere with the appropriate conduct of the study.
- •Any changes of immunosuppressive regimen due to graft malfunction, or any known clinically significant physical and/or laboratory changes in the 2 months prior to Screening visit.
- •Known positivity for HIV, HBsAg
- •Active viral hepatitis, as shown by liver function tests (AST or ALT) higher than twice the upper limit of normality
- •Evidence of drug and/or alcohol abuse Other inclusion/exclusion criteria may apply
结局指标
主要结局
Incidence of biopsy prove acute rejection requiring treatment within six months of the start of the study.
次要结局
- Assessment of the changes in body-weight, blood pressure, serum lipid levels, renal function, glaciated hemoglobin, dermatological condition and quality of life six months after the start of the study
- Safety and tolerability
- Pharmacokinetics of MPA and MPAG in the patient subgroup that was receiving MMF (screening period) before the start of the study and two weeks after the start of the administration of EC-MPS.
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
Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) Plus Valsartan in Patients With Kidney Transplants (MYTHOSDe Novo Renal TransplantationNCT00308425Novartis119
已完成
4 期
Safety and Tolerability of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients With GI IntoleranceRenal TransplantationNCT00150020Novartis728
已完成
4 期
Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant PatientsKidney TransplantationNCT00239083Novartis40
尚未招募
4 期
Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant RecipientsKidney Transplant RejectionNCT05872568Zhishui Chen270