The primary objective of this study is to assess the safety and tolerability of KN060 in patients with end-stage renal disease on regular hemodialysis. The secondary objectives to evaluate the pharmacokinetic and pharmacodynamic properties of multiple doses of KN060; to evaluate the immunogenicity of KN060; and to explore the efficacy of KN060 in preventing dialyzer and extracorporeal circuit thrombosis, arteriovenous fistula thrombosis in patients with end-stage renal disease undergoing regular hemodialysis. The main questions it aims to answer are: * Whether KN060 is safe for ESRD dialysis patients * Pharmacokinetic characteristics of KN060 in ESRD dialysis patients * Whether KN060 can effectively prevent dialyzer and extracorporeal circuit thrombosis Researchers will evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics profile, dialyzer and extracorporeal circuit thrombosis, arteriovenous fistula thrombosis of KN060 in ESRD dialysis patients Subjects will : * Eligible subjects will receive KN060 2.5 mg/kg every two weeks for a total of 6 doses. * Assessed for the number, incidence, and severity of AEs, dialyzer thrombus, extracorporeal circuit thrombus, arteriovenous fistula thrombus, and time to hemostasis at the arteriovenous fistula puncture site.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
12
pharmacokinetic and pharmacodynamic characteristics of KN060 in ESRD on Hemodialysis
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGSafety Results
Number, frequency, incidence and severity of treatment-emergent adverse events (TEAEs), drug-related adverse events (TRAEs), adverse events of special interest (AESIs), serious adverse events (SAEs), etc.
Time frame: up to 18 weeks
Pharmacokinetics characteristics
Trough blood concentration after reaching stability (C min,ss )
Time frame: up to 18 weeks
Pharmacodynamic characteristics
Pharmacodynamic characteristics after multiple administrations, pharmacodynamic indicators include: total coagulation factor XI ( Total FXI ), free FXI ( Free FXI ), activated partial thromboplastin time ( APTT ) and FXI activity; After the blood drug concentration reached a stable level, the occurrence of achieving \>50% or 95% inhibition of FXI;
Time frame: up to 18 weeks
Immunogenicity Results
The number and ratio of patients who produced anti-KN060 antibodies (ADA); the number and ratio of patients who produced anti-KN060 neutralizing antibodies (NAb) (NAb testing will be performed only on ADA-positive samples)
Time frame: up to 18 weeks
Bleeding Events
Number, frequency, and incidence of major bleeding events, clinically relevant non-major bleeding (CRNM) events, and all bleeding events;
Time frame: up to 18 weeks
Thrombosis events
Number, frequency, incidence and severity of dialyzer and extracorporeal circuit thrombosis, and arteriovenous fistula thrombosis
Time frame: up to 18 weeks
Time to hemostasis
Time to hemostasis at the arteriovenous fistula puncture site
Time frame: up to 18 weeks
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