CTIS2023-507977-16-00招募中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) - ALXN1210-NEPH-202
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 145
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
- 18 至 65+（—）
- 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.
排除标准
- •Common to both disease cohorts: - Estimated GFR < 30 mL/min/1.73 m^2 - Previously received a complement inhibitor (eg, eculizumab) at any time - Concomitant significant renal disease other than LN or IgAN - History of kidney transplant or planned kidney transplant during the Treatment Period - 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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