EUCTR2013-000226-55-NL进行中（未招募）不适用
European Multicenter and Open-Label Controlled Randomized Trial to evaluate the Efficacy of Sequential Treatment with Tacrolimus-Rituximab versus Steroids plus Cyclophosphamide in patientes with Primary Membranous Nephropathy - STARME
Fundacion Renal Iñigo Alvarez Toledo0 个研究点目标入组 175 人开始时间: 2014年6月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 175
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients are willing and are able to read and correctly understand the patient?s information sheet and give their consent for participation in the study (by correctly signing and dating the informed consent form document, which has been previously approved by an Ethics Committee/ International Review Board), before initiating any protocol-specific selection procedure
- •- Ability to understand study procedures and to comply with them for the entire length of the study.
- •- Age over 18 years.
- •- Biopsy-proven primary MN whitin the last two years. Patients with nephrotic syndrome relapse after remission (either spontaneous or induced by immunosupression) can be included without a new renal biopsy, provided that they meet all the other inclusion/exclusion criteria.
- •- Estimated GFR >= 45 ml/min/1.73m2.
- •- Nephrotic-range proteinuria (>4 g/day and remaining >50% of the baseline value) accompanied by hypoalbuminemia (<3 g/dL) during at least a six-month period before screening.
- •- Treatment with an ACEI or ARB for at least 2 months before screening, with a controlled blood pressure in at least last three months (target < 140/90 mmHg).
- •- Negative urine pregnancy test for female potentially fertile.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 125
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Diagnosis of secondary causes of membranous nephropathy: diagnosis of type 1 or 2 diabetes mellitus, malignancy (cancer), systemic infections (which include viral, malaria, B and C hepatitis, leprosy and syphilis), systemic autoimmune diseases (e.g. Systemic Lupus Erythematosus; SLE), amyloidosis, or any other acute or chronic inflammatory disease.
- •- HIV infection.
- •- Moderate or severe liver disease (AST and ALT > 2.5x upper range limit and total bilirrubin > 1.5 x upper range limit).
- •- Patients are taking part in any other study with an investigational study and/or are receiving or have received treatment with another investigational drug or intervention (within the first month prior to the study).
- •- Suspected or known hypersensitivity, allergy and/or immunogenic reaction history of either rituximab, cyclosporine, tacrolimus, corticosteroids, CYC or any of their ingredients (which include excipients) and of any other drug from the same pharmacotherapeutic group (i.e. calcineurin inhibitors, specific monoclonal antibodies or alkylating agents).
- •- Previous treatment with corticosteroids or any other immunosuppressive drug in the two-year period before screening.
- •- Patients who were non responders to previous immunosuppressors.
- •- Women showing a positive pregnancy test or during lactation period or plans to become pregnant. Women not using contraceptive methods during the complete study.
- •- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
- •- Any other medical unstable, uncontrolled, or severe condition or any other relevant laboratory test finding which, at the investigator?s own discretion, could possibly increase the associated risk of the patient?s participation in the study.
- •- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
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