A Sequential Phase 2/3 Study of APL2 in Patients With Focal Segmental Glomerulosclerosis

Exclusion Criteria

• •Previous exposure to APL2
• •Evidence of improving kidney disease in the 8 weeks prior to screening or during the screening period according to available data
• •FSGS secondary to another condition (eg, infectious, diabetic, drug-induced, obesity, prematurity, sickle-cell, vesicoureteral reflux, congenital anomalies of the kidney, and urinary tract)
• •Type 1 or uncontrolled (HbA1C ≥8%) type 2 diabetes mellitus
• •History of kidney transplant
• •Current or prior diagnosis of HIV, hepatitis B, or hepatitis C infection or positive serology or viral load during screening that is indicative of active infection with any of these viruses
• •Hypersensitivity to APL2 or to any of the excipients
• •Significant other kidney disease that would, in the opinion of the investigator, confound interpretation of study results
• •Use of rituximab, belimumab, or any approved or investigational anticomplement therapy within 5 half-lives of that product prior to the screening period