New drug aims to stop blood clots during dialysis

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female subjects aged between 18 and 80 years (inclusive); 2. 1 8 kg /m \^2 \<BMI \<2 8 kg /m\^2 ; 3. Diagnosis of ESRD and be receiving regular, stable hemodialysis treatment within the three months prior to screening: dialysis is performed through a functional, non-infected graft arteriovenous fistula / autologous arteriovenous fistula ( AVG/AVF ) ; dialysis is performed three times per week, with at least 3.5 hours per session ( at least 75% of dialysis sessions within the four weeks prior to randomization meet the this criteria) ; 4. The clinical status of the underlying ESRD is stable (assessed by the investigator) ; 5. Kt/V ≥ 1.2 within 3 months before screening ; 6. Male subjects: From the time they sign the informed consent form until 3 months after the last dose of KN060 , they agree to take effective contraceptive measures and avoid sperm donation ( effective contraceptive methods include: consistent scientific use of condoms , vasectomy , or partners who have undergone tubal ligation or hysterectomy, or have an intrauterine device implanted, etc. ); 7. Women who are infertile and have no plans to have children (surgical infertility: such as after hysterectomy, bilateral salpingectomy , bilateral oophorectomy; or natural menopause: amenorrhea for ≥ 12 months and serum follicle-stimulating hormone (FSH) at menopausal levels ). Exclusion Criteria: 1. A history of malignant tumor; 2. History of mechanical/artificial heart valve replacement surgery; 3. History of major medical events within 3 months before screening , such as acute coronary syndrome, stroke , major organ bleeding, acute heart failure, systemic thromboembolic events , major surgery, etc. , or history of AVF/AVG functional loss; 4. Using anticoagulant/antiplatelet drugs due to disease treatment , such as warfarin , dabigatran, rivaroxaban , clopidogrel , or aspirin \>100 mg/day (investigators are allowed to use heparin / low molecular weight heparin during dialysis, depending on the situation ); 5. There is a high risk of bleeding, or abnormal bleeding-related indicators: 1） Bleeding requiring hospitalization or clinically significant active bleeding within 3 months before screening ; prolonged arteriovenous fistula compression time within the past month; 2） Platelet count (PLT) \<100 × 10\^ 9 /L ( PLT between 75-100 × 10\^9 /L , determined by the investigator after comprehensive evaluation), hemoglobin ( Hb ) \< 90 g/L ; 3） Normalized ratio INR\>1.4 , activated partial thromboplastin time ( APTT ) \> 1.2 times ULN ; 4） Liver disease-related laboratory abnormalities: increased bleeding risk due to coagulation disorders , alanine aminotransferase (ALT) \> 3 times ULN , aspartate aminotransferase ( AST) \> 3 times ULN , total bilirubin (TB) \> 2 times ULN and direct bilirubin proportion \> 20%; 5） Poor blood pressure control in the past month before screening (judged by the investigator, such as repeated diastolic blood pressure ≥100 mmHg and/or systolic blood pressure ≥180 mmHg ) ; 6） Underwent brain, spinal or eye surgery (excluding cataract surgery) within three months before screening; 7） The patient has a bleeding disorder, a medical history that may increase the risk of bleeding, any condition that the investigator believes increases the risk of bleeding, or a history of severe bleeding disorders, such as massive gastrointestinal bleeding or cerebral hemorrhage ; 6. Supine blood pressure is \< 90/50 mmHg , or \> 170/100 mmHg (one retest is allowed) during screening; 7. Electrocardiogram during screening: heart rate \< 45 beats / min or \> 110 beats / min, QTcF \> 500 ms, any significant arrhythmia or conduction abnormality ( e.g. Second degree or above atrioventricular block, preexcitation syndrome (except those who have undergone radical radiofrequency ablation) , non-sustained or sustained ventricular tachycardia (one retest is allowed); 8. History (\<1 year) of drug or alcohol abuse or dependence before screening; 9. Have a history of allergy, or be allergic to the experimental drug/similar drugs or excipients; 10. Human immunodeficiency virus (HIV ) infection, syphilis infection, active HBV infection (HBV -DNA\>ULN ), active HCV infection (HCV - RNA \> ULN ) ; 11. Participated in another clinical trial and received trial drugs within 3 months before screening (signing ICF); 12. Plan to receive a kidney transplant during the trial or within 3 months after completing this trial; 13. Xanthine, coffee (small amounts of caffeine from normal food sources, such as chocolate, are permitted), or alcohol cannot be prohibited during the study; 14. Any concomitant disease or condition that the investigator believes may interfere with the study drug, affect study data, or pose a risk to patient safety.