EUCTR2020-001537-13-ES进行中（未招募）1 期
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) - Ravulizumab in LN or IgA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •Common to both disease cohorts:
- •- 18 - 75 years of age
- •- Proteinuria = 1 (g/d or g/g)
- •- Vaccinated against meningococcal infection
- •- Vaccinated against Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae
- •For LN cohort:
- •- Diagnosis of active focal or diffuse proliferative LN Class III or IV
- •- Clinical active LN, requiring/receiving immunosuppression induction treatment
- •For IgAN cohort:
- •- Diagnosis of primary IgAN
- •- Compliance with stable and optimal dose of RAS inhibitor treatment for = 3 months
- •For a full list of inclusion criteria please refer to the clinical study protocol, section 5.1.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 108
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •Common to both disease cohorts:
- •- Estimated GFR < 30 mL/min/1.73 m2
- •- Previously received a complement inhibitor (eg, eculizumab) at any time
- •- Concomitant significant renal disease other than LN or IgAN
- •- History of other solid organ or bone marrow transplant
- •- Uncontrolled hypertension
- •For IgAN cohort:
- •- Diagnosis of rapid progressive glomerulonephritis
- •- Prednisone or prednisone equivalent > 20 mg for > 14 consecutive days or any other immunosuppression within 6 months
- •For a full list of exclusion criteria please refer to the clinical study protocol, section 5.2.
研究者
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