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. 2024 Oct 4;17(10):sfae270. doi: 10.1093/ckj/sfae270

Table 3:

Trials evaluating the effects of FXI inhibition in kidney failure.

Study Population Intervention Number of participants Primary outcome Status
CS4, NCT02553889 (Phase 2) Kidney failure treated with hemodialysis Fesomersen (FXI antisense oligonucleotid) vs placebo 49 Safety and tolerability Completed and published [72]
EMERALD, NCT03358030 (Phase 2) Kidney failure treated with hemodialysis IS 416858 (FXI antisense oligonucleotid) vs placebo 213 Number of participants with major bleeding or clinically relevant non major bleeding Completed, results on clinicaltrials.gov, not yet published
RE-THINc ESRD, NCT04534114 (Phase 2b) Kidney failure treated with hemodialysis Fesomersen (FXI antisense oligonucelotid) vs placebo 307 Incidence of major bleeding or clinically relevant non major bleeding Completed and published [66]
FXI Hemodialysis Study, NCT05027074 (Phase 2) Kidney failure treated with hemodialysis via arteriovenous graft MK-2060 (anti-FXI monoclonal antibody) vs placebo 489 Time to first arteriovenous graft thrombosis Active, not yet recruiting
AB023, NCT03612856 (Phase 2) Kidney failure treated with hemodialysis AB023 (Xisomab, anti-FXI monoclonal antibody) vs placebo 27 Number of treatment-related adverse events Completed and published [73]
CONVERT, NCT04523220 (Phase 2b) Kidney failure treated with hemodialysis Osocimab (anti-FXI monoclonal antibody) vs placebo 704 Cumulative incidence of risk of the first major bleeding or clinically relevant non major bleeding Completed and published [65]