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

ovartis Farmacéutica, S.A.0 个研究点目标入组 170 人开始时间: 2019年9月4日最近更新: 2019年12月16日

适应症

试验速览

暂无简介。

•o Confirmed diagnosis of SCD (HbSS and HbSß0-thal SCD genotypes are eligible)
•o Patients with eGFR = 45 to = 120 mL/min/1.73 m2 based on CKD EPI formula
•o Patients with ACR of = 100 to < 2000 mg/g
•o Receiving standard of care drug(s) for SCD for at least 6 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
•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 160
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3

•o History of stem cell transplant - Patients with evidence of AKI within 3 months of study entry
•o Blood pressure > 140/90 mmHg despite treatment
•o Patients undergoing hemodialysis
•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
•Additional protocol-defined exclusion criteria may apply

发起方

ovartis Farmacéutica, S.A.