Table 1.

Key inclusion and exclusion criteria

Inclusion	Exclusion
Aged ≥18 yrs	Treatment with complement inhibitors, including anti-C5 antibody
Evidence of TMA, including thrombocytopenia, evidence of hemolysis, and acute worsening of kidney function	ADAMTS13 deficiency (<10% activity)
	Shiga toxin-related HUS
	Positive direct Coombs test
Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae	Known diacylglycerol kinase mediated HUS
	Identified drug exposure-related HUS
	HUS related to known genetic defects of cobalamin C metabolism
Patients with a kidney transplant are permitted; however, must: (a) have a known history of aHUS before current kidney transplantation, or (b) have no known history of aHUS, and persistent evidence of TMA at least 4 days after modifying the immunosuppressive regimen	Receiving plasma exchange/plasma infusion for ≥28 days before the start of screening for the current TMA
	Bone marrow/hematopoietic stem cell transplantation, heart, lung, small bowel, pancreas, or liver transplantation
	Patients with sepsis, severe systemic infection, COVID-19 infection, systemic infection which confounds an accurate diagnosis or impedes management of aHUS,
	Patients with a history of recurrent invasive infections caused by encapsulated bacteria
	Systemic sclerosis, systemic lupus erythematosus or antiphospholipid antibody positivity or syndrome, or any other autoimmune disease associated with HUS
	Chronic hemodialysis or peritoneal dialysis

ADAMTS13, a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13; HUS, hemolytic uremic syndrome; TMA, thrombotic microangiopathy.

Other protocol-defined inclusion/exclusion criteria may apply.