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)

ovartis Pharma AG0 个研究点目标入组 41 人开始时间: 2020年5月27日最近更新: 2023年5月29日

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•Male and female patients = 16 years on the day that signed informed consent is obtained
•Confirmed diagnosis of SCD by hemoglobin (Hb) electrophoresis or high performance liquid chromatography [performed locally]. HbSS and HbSß0 thal SCD genotypes are eligible
•Patients with eGFR = 45 to = 120 mL/min/1.73 m2 based on Chronic Kidney Disease Epidemiology Collaboration formula
•Patients with ACR of = 100 to < 2000 mg/g
•Receiving standard of care drug(s) for SCD and/or CKD. If receiving hydroxyurea (HU)/hydroxycarbamide (HC), angiotensin converting enzyme (ACE) inhibitor, and/or angiotensin receptor blocker (ARB) (and still with abnormal ACR despite treatment), must have been receiving the drug(s) for at least 6 months prior to study entry and plan to continue taking the drug(s) at the same dose and schedule until the patient has reached the end of the study
•Hb = 4.0 g/dL, absolute neutrophil count = 1.0 x 109/L, and platelet count = 75 x 109/L
•Patients who are clinically stable and are in a non crisis state

•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 (pre-planned series of transfusions for prophylactic purposes). Transfusions for acute complications are permitted (acute chest syndrome, acute splenic sequestration, acute hepatic sequestration, worsened anemia)
•History of kidney transplant
•Patients with hypoalbuminemia
•Use of therapeutic anticoagulation or antiplatelet therapy (other than aspirin or non steroid anti inflammatory drugs) within the 10 days prior to Week 1 Day 1. Note: Prophylactic anticoagulant dose is permitted, as per local guidelines
•Patients with active human immunodeficiency virus, Hepatitis B and Hepatitis C infection
•Evidence of CKD attributed to causes other than SCN

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