NCT01763580已完成4 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 144
- 主要终点
- The percentage of subjects who show a decreased UPCR (Urine Protein Creatinine Rate) of less than 0.2
研究概览
简要总结
To compare the therapeutic effect of tacrolimus in combination with low-dose corticosteroid with high-dose corticosteroid alone in patients with minimal-change nephrotic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 78 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who have been diagnosed with initial or relapsed primary minimal-change nephrotic syndrome
- •patients whose urine protein-creatinine ratio (UPCR) is more than 3.0
排除标准
- •patients whose eGFR is less than 30 ml/min/1.73 m2
- •patients who were treated with immunosuppressants, such as tacrolimus, cyclosporine, cyclophosphamide (Cytoxan), mizoribine (Bredinin), levamisole, azathioprine, mycophenolate mofetil, or rituximab, within two weeks before the study
- •patients to whom more than 10 mg prednisolone or an equivalent dose of steroid was administered daily within two weeks before the study
- •patients who are pregnant, breastfeeding, or planning to be pregnant or to breastfeed within six months after the study completion, or who cannot or do not want to use any contraceptive method
- •patients who are hypersensitive to the investigational drug or to macrolide, such as azithromycin, clarithromycin, or roxithromycin
- •patients who were treated with a live vaccine within four weeks before the study
- •patients whose liver panel laboratory test result is three times the normal range, or acute hepatitis patients whose serum bilirubin has been clinically significantly higher than 3.6 mg/dL for more than 1 month
- •patients who have a significant general disease that makes it inappropriate for them to participate in this study as adjudged by the investigator (e.g., cardiovascular-acute myocardial infarction, heart failure [classified as more than New York Heart Association {NYHA} class III], hepatic/gastrointestinal/neurologic disease, blood disorder, cancer, infection, renal disorder other than minimal-change nephrotic syndrome, rheumatic arthritis with pneumonia interstitials)
- •patients who have genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
- •patients to whom another investigational drug was administered within 30 days from the enrollment in the study
- •patients who participated in the past phases of this study
研究组 & 干预措施
Tacrolimus with low-dose corticosteroid
Experimental
Oral
干预措施: Tacrolimus (Drug)
Tacrolimus with low-dose corticosteroid
Experimental
Oral
干预措施: Prednisolone (Drug)
High-dose corticosteroid alone
Active Comparator
Oral
干预措施: Prednisolone (Drug)
结局指标
主要结局
The percentage of subjects who show a decreased UPCR (Urine Protein Creatinine Rate) of less than 0.2
时间窗: up to 8 weeks after treatment
次要结局
- The period until the UPCR is decreased below 0.2(up to 8 weeks after treatment)
- The period until the relapse happens from the complete remission(up to 24 weeks)
- Safety assessed by the incidence of adverse events, labo-tests, vital signs, ECGs and chest X-rays(up to 24 weeks)
- The percentage of subjects who show relapse after the remission(up to 24 weeks)
研究者
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