NL-OMON44594已完成3 期
SEQUENTIAL THERAPY WITH TACROLIMUS AND RITUXIMAB IN PRIMARY MEMBRANOUS NEPHROPATHY - STARME
Sociedad Española de Nefrologia (senefro), prof. Manuel Praga0 个研究点目标入组 7 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Biopsy-proven primary MN. Patients with nephrotic syndrome relapse after remission (either spontaneous or induced by immunosuppression) can be included without a new renal biopsy, provided that they meet all the other inclusion/exclusion criteria.
- •2. Age older than 18 years.
- •3. Estimated GFR > 45 ml/min/1.73m2 in at least two measurements performed within the two weeks prior to randomization
- •4. 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. Proteinuria should be >4 g/day and serum albumin <3 g/dl in at least two measurements performed within the two weeks prior to randomization.Those patients showing severe or disabling symptons related to the nephrotic syndrome or severe hypoalbuminemia (<2 g/dL) can be included before the completion of this 6-month observation period, at the investigator*s discretion.
- •5. Treatment with an ACEI or ARB for at least 2 months before screening (unless intolerance to ACEI/ARB, contraindications to their use or a low blood pressure that could induce side effects at the investigator*s discretion) with a controlled blood pressure in at least last three months (target < 140/90 mmHg).
- •6. Negative urine pregnancy test for female potentially fertile.
排除标准
- •1. Diagnosis of secondary causes of membranous nephropathy: diagnosis of malignancy (cancer), systemic infections (which include viral, malaria, B and C hepatitis, leprosy and syphilis), systemic autoimmune diseases (e.g. Systemic Lupus Erythematosus; SLE), or any other acute or chronic inflammatory disease.
- •2. HIV infection.
- •3.Moderate or severe liver disease (AST and ALT > 2.5x upper range limit and total bilirubin > 1.5 x upper range limit).
- •4. 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).
- •5.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).
- •6.Previous treatment with corticosteroids or any other immunosuppressive drug in the two-year period before screening.
- •7. Patients who were non responders to previous immunosuppressors.
- •8.Women showing a positive pregnancy test or during lactation period or plans to become pregnant. Women not using contraceptive methods during the complete study.
- •9.Inability or unwillingness of individual to give written informed consent.
- •10.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.
- •11. 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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