Multi-center, Randomized, Open Label, Comparative, Phase IV Study to Evaluate the Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid for 48 Weeks in Advanced IgA Nephropathy
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Remission rate (complete / partial)
研究概览
简要总结
The purpose of this clinical study is to evaluate the efficacy and safety of that test group was administered with Mycophenolate Mofetil in combination with corticosteroid in patients with advanced IgA nephropathy. The control group will be observed for up to 48 weeks without administration of Mycophenolate Mofetil.
详细描述
The subject who signed the written agreement to participate in the clinical trial evaluates the conformity and then 1: 1 randomly allocated.
The study group were taken 48 weeks with MYREPT ® capsules in combination with corticosteroids and the control group were asked to preserve the conservative treatment regimen prior to the clinical trial registration Maintenance.
The subject who started taking the study medicine will carry out the examination and procedure if it has to be carried out for the visit via outpatient clinic at 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •If eGFR (by MDRD) is <15 mL / min / 1.73 m^2
- •Blood pressure is SBP> 160 mmHg or DBP> 100 mmHg
- •Systemic infection or have been diagnosed with cancer within the last 5 years (excluding treatment squamous cell or basal cell carcinoma skin cancer)
- •serious digestive disorder
- •WBC <3000 / mm^3
- •Acute (within 4 weeks) or chronic(need to treatments) allergic/hypersensitivity reaction in the history of Investigational drugs
- •Administration of other Investigational drugs within 28days before screening period
- •Administration of Investigator drug or other immunosuppressants within 84days before screening period
- •Women in pregnant or breast-feeding or don't using adequate contraception.
- •Patient has conversation impairment because alcohol or drugs addiction history within 6months or mental illness, etc.
- •In investigator's judgment
研究组 & 干预措施
Mycophenolate Mofetil
MYREPT® capsule(CKDpharm, KOREA) and corticosteroid
干预措施: Mycophenolate Mofetil (Drug)
Mycophenolate Mofetil
MYREPT® capsule(CKDpharm, KOREA) and corticosteroid
干预措施: Corticosteroid (Drug)
Conservative treatment
maintain conservative treatment (ACE inhibitor or ARB)
干预措施: ACE inhibitor (Drug)
Conservative treatment
maintain conservative treatment (ACE inhibitor or ARB)
干预措施: ARB (Drug)
结局指标
主要结局
Remission rate (complete / partial)
时间窗: up to 48 weeks
次要结局
- Remission rate (complete / partial)(at 12 weeks, at 24 weeks, at 36 weeks)
- eGFR(estimated glomerular filtration rate) by MDRD(modification of diet in renal disease)(at 24 weeks, at 36 weeks, at 48 weeks)
- The incidence of renal replacement therapy(up to 48 weeks)
- The average time to occurrence of renal replacement therapy(up to 48 weeks)