JPRN-jRCT2011210060招募中3 期
The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis - IRIS
Ageishi Yuji0 个研究点目标入组 360 人开始时间: 2021年12月26日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 360
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
- >= 18age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •1. Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classification
- •2. Renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period.
- •3. Urine protein to creatinine ratio > 1 mg/mg (113.17 mg/mmol)
- •4. eGFR 35 mL/min/1.73 m2 or more (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
- •5. Fulfills updated 2019 EULAR/ACR SLE classification criteria.
- •6. No signs of symptoms of active TB prior to or during screening or no treatment for latent TB
排除标准
- •1. A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening.
- •2. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV confirmed by the central lab at Screening - an HIV test must be performed during Screening, and the result should be available prior to Week 0 (Day 1).
- •3. Evidence of hepatitis C or active hepatitis B.
- •4. Any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ.
- •5. Receipt of the following for the current LN flare (ie, since the qualifying renal biopsy): IV cyclophosphamide > 2 pulses of high-dose (0.5 g/m2 or more) or > 4 doses of low dose (500 mg every 2 weeks) or Average MMF > 2.5 g/day (or > 1800 mg/day of enteric coated mycophenolate sodium) for more than 8 weeks or Tacrolimus > 4 mg/day for more than 8 weeks; Cyclosporine for more than 8 weeks or during last 8 weeks prior to signing the ICF; Voclosporin for more than 8 weeks or during last 8 weeks prior to signing the ICF; Belimumab for more than 12 weeks or during last 12 weeks prior the ICF.
- •6. Previous receipt of >=2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through the ICF.
- •7. Known intolerance to 1.0 g/day of MMF or less.
- •8. Any history of severe COVID-19 infection.