NL-OMON55208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 - CSEG101A2203 -STEADFAST
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 4
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 99（—）
入选标准
- •1. Male and female patients * 16 years on the day that signed informed consent
- •is obtained
- •2. Confirmed diagnosis of SCD. Homozygous HbS and HbS*0-thal SCD genotypes are
- •3. 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)
- •4. ACR of * 100 to < 2000 mg/g (taken as an average of the three screening ACR
- •values to determine eligibility)
- •5. Receiving standard of care drug(s) for SCD and/or CKD.
- •6. Hb * 4.0 g/dL, ANC * 1.0 x 109/L, and platelet count * 75 x 109/L
- •7. ECOG performance status * 2.0
排除标准
- •1. History of stem cell transplant
- •2. 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)
- •3. Blood pressure > 140/90 mmHg despite treatment
- •4.Patients undergoing renal replacement therapy (i.e. hemodialysis, peritoneal
- •dialysis, hemofiltration and kidney transplantation)
- •5. Participating in a chronic transfusion program
- •6. History of kidney transplant
- •7. Patients with hypoalbuminemia
- •8.Patient has received crizanlizumab and/or other selectin inhibitor or plans
- •to receive it during the duration of the study
- •9. History of or current diagnosis of ECG abnormalities indicating significant
- •risk of safety
- •10. Current drug or alcohol abuse:
- •11. Pregnant or nursing (lactating) women
研究者
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