> 16 Years
SS, Sβ0-thal
Phase 2
The goal of the study is to compare the efficacy and safety 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.
– Confirmed diagnosis of SCD (HbSS and HbSβ0-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
– 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
Other protocol-defined inclusion/exclusion criteria may apply