EUCTR2018-003608-38-IE进行中（未招募）1 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 (STEADFAST) - STEADFAST
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 148
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
- •o Confirmed diagnosis of SCD (HbSS and HbSß0-thal SCD genotypes are eligible)
- •o Patients with eGFR = 45 to = 140 mL/min/1.73 m2 based on CKD EPI formula (patients = 18) or the Creatinine-based Bedside Schwartz
- •equation (patients < 18)
- •o Patients with ACR of = 100 to < 2000 mg/g (taken as an average of
- •the three screening ACR values to determine eligibility)
- •o Receiving at least 1 standard of care drug(s) for SCD related CKD according to local guidelines. if receiving HU/HC, the patient must have been receiving HU/HC for at least 6 months and on a stable dose for 3 months prior to study entry
- •o Written informed consent (or assent/ parental consent for minor subjects) prior to any screening procedures
- •Additional inclusion criteria as per full protocol may apply.
- •Additional inclusion criteria as per full protocol may apply
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 7
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 138
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •o History of stem cell transplant
- •o Patients with evidence of AKI within 3 months of study entry (can
- •decrease interval to within 6 weeks of study entry only if renal function has returned to pre-AKI values prior to study entry)
- •o Blood pressure > 140/90 mmHg despite treatment
- •o Body mass index of = 35
- •o Patients undergoing renal replacement therapy (ie. hemodialysis, peritoneal dialysis, hemofiltration and kidney transplantation)
- •o Received blood products within 30 days of Week 1 Day 1
- •o Participating in a chronic transfusion program
- •o History of kidney transplant
- •o Patients with hypoalbuminemia defined as <25 g/L
- •Additional protocol-defined exclusion criteria may apply
研究者
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