Actively Recruiting
To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN060 in ESRD Dialysis Patients
Led by Suzhou Alphamab Co., Ltd. · Updated on 2025-10-01
12
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN060 in ESRD Dialysis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged between 18 and 80 years (inclusive)
- Body mass index (BMI) between 18 kg/m² and 28 kg/m²
- Diagnosis of end-stage renal disease receiving regular, stable hemodialysis for at least three months
- Hemodialysis performed through a functional, non-infected arteriovenous fistula or graft
- Dialysis frequency of three times per week, with at least 3.5 hours per session and 75% compliance in the four weeks before randomization
- Stable clinical status of ESRD as assessed by the investigator
- Kt/V value of 1.2 or greater within three months before screening
- Male participants agree to use effective contraception and avoid sperm donation from consent until three months after last dose
- Women who are infertile with no plans to have children due to surgical infertility or natural menopause
You will not qualify if you...
- History of malignant tumor
- History of mechanical or artificial heart valve replacement surgery
- Major medical events within three months before screening such as acute coronary syndrome, stroke, major bleeding, acute heart failure, systemic thromboembolic events, major surgery, or arteriovenous fistula/graft loss
- Use of anticoagulant or antiplatelet drugs for disease treatment, except heparin or low molecular weight heparin during dialysis
- High bleeding risk or abnormal bleeding-related lab values including recent bleeding, low platelet count, low hemoglobin, high INR or APTT, liver disease with coagulation abnormalities, or poor blood pressure control
- Brain, spinal, or eye surgery (excluding cataract) within three months before screening
- History or risk of bleeding disorders or severe bleeding events
- Supine blood pressure below 90/50 mmHg or above 170/100 mmHg during screening
- Abnormal electrocardiogram findings including extreme heart rates, prolonged QTc, significant arrhythmias or conduction abnormalities
- History of drug or alcohol abuse within one year before screening
- Allergy to the study drug or similar compounds
- Infection with HIV, syphilis, active hepatitis B or C
- Participation in another clinical trial with investigational drugs within three months before screening
- Planning kidney transplant during the study or within three months after
- Inability to avoid xanthine, caffeine, or alcohol during the study
- Any other medical condition that may interfere with the study or pose risk as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
Y
Yanrong Dong, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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