A Randomized Open-label Study of Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Response rate at 48 week of therapy
研究概览
简要总结
A randomized open-label study of fixed-dose versus concentration-controlled mycophenolate mofetil for treatment of active lupus nephritis.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 year
- •Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE
- •Active lupus nephritis (both new and flare patients can be included) defined as:
- •Within 16 weeks of randomization, had Biopsy-proven ISN class III or IV [exclude III(c), IV-S(c) and IV-G(c). Patients are permitted to have co-existing class V and
- •At screening day, has urine protein creatinine ratio (UPCR) or 24-hour urinary protein ≥ 1.0 g/g or g/day
排除标准
- •Pregnancy or breast feeding
- •Child-bearing age women who refuse to use effective birth-control
- •Poor compliance
- •Estimated-GFR < 20 mL/min/1.73 m2
- •Crescentic glomeruli more than 30 percent
- •Severe extra-renal involvement of SLE
- •History of severe allergic reactions or adverse effects to MMF
- •Uncontrolled concomitant disease
- •Known active, clinically significant infection of any kind
- •History of serious recurrent or chronic infection
- •History of malignancy (except basal cell carcinoma, squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been excised and cured)
- •Concomitant conditions which has required treatment with systemic corticosteroid (excluding topical or inhaled steroids) at any time in the 52 weeks prior to screening
- •Treatment with more than 1 g cyclophosphamide within the past 24 weeks
- •Receipt more than 3 g of IV pulse methylprednisolone within the past 12 weeks
- •Receipt prednisolone more than 30 mg/day for longer than 30 days within the past 12 weeks
- •Treatment with MMF at ≥ 1.5 g/day for over 4 weeks within the past 12 weeks
- •On treatment with Tacrolimus or Cyclosporine on the day of screening
- •Treatment with any biologic B-cell depleting therapy (e.g. anti CD-20, anti CD 22) within 52 weeks
- •Receiving concomitant medication interfering PK of MPA
- •Cholestyramine
研究组 & 干预措施
FD arm
MMF will be prescribed at a starting dose of 1.5 g/day and increased to 2 g/day at week 4 (if body weight ≥ 45 kg) and continue the same dose until week 24. After week 24, MMF will be lowered to 1.5 g/day.
干预措施: Mycophenolate Mofetil (Drug)
CC Arm
MMF will be prescribed at a starting dose of 1.5 g/day. MPA-C0 (trough) level will be measured weekly and MMF dose will be increased by 500 mg/day every week until the MPA-C0 level ≥ 3 mg/L or the MMF dosage is 3000 mg/day. After achieving the targeted MPA-C0 level, the MMF dose adjustment will be allowed only if the MPA-C0 levels are lower than 3 mg/L for two consecutive monitoring visits. After week 12, MMF will be maintained at the same dose until week 48
干预措施: Mycophenolate Mofetil (Drug)
结局指标
主要结局
Response rate at 48 week of therapy
时间窗: 48 weeks
次要结局
- eGFR at 96, 144 and 240 week(96, 144 and 240 weeks)
- MPA-area under the curve (AUC) 0-4 hour at 12 week(12 weeks)
- Urine IP-10 levels(48 weeks)
- Relapse free survival at 96, 144 and 240 week(96, 144 and 240 weeks)
- Adverse events(48 weeks)
- Mycophenolic acid trough levels(48 weeks)
- C3 levels(48 weeks)
- Anti-dsDNA(48 weeks)
- Progression to CKD stage 3 or more at 96, 144 and 240 week(96, 144 and 240 weeks)
- End stage renal disease at 96, 144 and 240 week(96, 144 and 240 weeks)
研究者
Yingyos Avihingsanon
Professor
Chulalongkorn University