LBCTR2020094586已完成2 期
A Phase II, Multicenter, Randomized, Open Label Two Arm Study Comparing the Effect of Crizanlizumab + Standard of Care to Standard of Care Alone on Renal Function in Sickle Cell Disease Patients = 16 Years With Chronic Kidney Disease Due to Sickle Cell Nephropathy
ovartis Pharmaceuticals0 个研究点目标入组 1 人开始时间: 2024年3月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 16 至 99（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of SCD (HbSS and HbSß0-thal SCD genotypes are eligible)
- •- Patients with eGFR = 45 to = 120 mL/min/1.73 m2 based on CKD EPI formula
- •- Patients with ACR of = 100 to < 2000 mg/g
- •- Receiving standard of care drug(s) for SCD and/or CKD for at least 6 months prior to study entry
- •- Hb = 4.0 g/dL, absolute neutrophil count (ANC) = 1.0 x 109/L, and platelet count = 75 x 109/L
- •-Written informed consent (or assent/ parental consent for minor subjects) prior to any screening procedures
排除标准
- •History of stem cell transplant
- •- Patients with evidence of AKI within 3 months of study entry
- •- Blood pressure > 140/90 mmHg despite treatment
- •- Patients undergoing hemodialysis
- •- Received blood products within 30 days of Week 1 Day 1
- •- Participating in a chronic transfusion program
- •- History of kidney transplant
- •- Patients with hypoalbuminemia
研究者
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