EUCTR2015-001039-18-Outside-EU/EEA进行中（未招募）不适用
Open-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf [Cap.]®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS) - T_OPTIMUM study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 152
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
- •1) Male or female patients aged 16 or over–under 80
- •2) Patients who have been diagnosed with initial or relapsed primary minimal change nephrotic syndrome through a renal biopsy
- •3) Patients whose urine protein creatinine ratio (UPCR) measured at the screening visit is 3.0 or above (spot urine)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1) Patients whose MDRD eGFR < 30 ml/min/1.73m2
- •2) Patients who were treated with immunosuppressants, such as tacrolimus, cyclosporine, cyclophosphamide (Cytoxan), mizoribine (Bredinin), levamisole, azathioprine, mycophenolate mofetil or rituximab within two weeks before this clinical trial
- •3) Patients to whom more than 10 mg prednisolone or an equivalent dose of steroid was administered daily within two weeks before this clinical trial
- •4) Patients who are pregnant, breastfeeding, or planning to be pregnant or to breastfeed within six months after the study completion, or females of childbearing potential who do not agree to use effective contraceptive methods
- •5) Patients who are hypersensitive to the investigational drug or to macrolides, such as azithromycin, clarithromycin, or roxithromycin
- •6) Patients who are taking bosentan (Tracleer tablets)
- •7) Patients who are taking potassium-sparing diuretics
- •8) Patients who were treated with a live vaccine within four weeks before V1
- •9) Patients whose liver function test result is three times the upper limit of normal or clinically significant acute hepatitis patients whose serum bilirubin has been higher than 3.6 mg/dL for more than 1 month
- •10) Patients who have a significant general disease that makes it inappropriate for them to participate in this clinical trial as judged by the investigator (e.g., cardiovascular-acute myocardial infarction, heart failure classified as more than NYHA class III, hepatic/gastrointestinal/neurologic disease, blood disorder, cancer, infection, renal disorder other than minimal change nephrotic syndrome, rheumatoid arthritis with pneumonia interstitials, herpes simplex, herpes zoster, chicken pox, etc.)
- •11) Patients who have genetic problems, such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
- •12) Patients to whom another investigational drug was administered within the last 30 days
研究者
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