Actively Recruiting
Phase 1b Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KN060 in Patients With End-Stage Renal Disease Receiving Regular Hemodialysis
Led by Suzhou Alphamab Co., Ltd. · Updated on 2025-10-01
12
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of KN060 in patients with end-stage renal disease (ESRD) who are on regular hemodialysis. This study also aims to explore how the body processes and responds to multiple doses of KN060, its immunogenicity, and its potential to prevent blood clots in the dialysis circuit and arteriovenous fistula in this patient group. The main questions focus on safety, pharmacokinetics, and prevention of thrombosis in ESRD dialysis patients. Eligible participants will receive KN060 at a dose of 2.5 mg/kg every two weeks for a total of six doses. The drug is administered via the arterial line of the dialysis circuit, diluted in normal saline. This phase 1b study observes patients during treatment to assess safety and pharmacological effects over approximately 18 weeks. Participants will be closely monitored for adverse events, incidence and severity of blood clots in the dialyzer and extracorporeal circuit, and thrombosis of the arteriovenous fistula. The time it takes for bleeding to stop at the fistula puncture site will also be recorded. Safety and pharmacokinetic data will be collected throughout the study period, with follow-up assessments during and after dosing to evaluate the drug's effects and tolerability.
CONDITIONS
Brief 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 (ESRD) and receiving stable, regular hemodialysis treatment for at least three months
- Dialysis performed through a functional, non-infected arteriovenous fistula or graft
- Dialysis sessions three times per week, each lasting at least 3.5 hours, with at least 75% of sessions meeting this duration in the past four weeks
- Stable clinical status of ESRD as assessed by the investigator
- Kt/V value of 1.2 or higher within three months before screening
- Male subjects agree to use effective contraception from consent until three months after last dose
- Women who are infertile with no plans for children (surgical infertility or natural menopause)
You will not qualify if you...
- History of malignant tumors
- History of mechanical or artificial heart valve replacement surgery
- Major medical events within three months before screening, including acute coronary syndrome, stroke, major organ bleeding, acute heart failure, systemic thromboembolic events, major surgery, or loss of arteriovenous fistula/graft function
- Use of anticoagulant or antiplatelet drugs for disease treatment (except heparin or low molecular weight heparin during dialysis)
- High risk of bleeding or abnormal bleeding-related lab values, including recent significant bleeding, low platelet count, low hemoglobin, abnormal coagulation tests, or liver-related lab abnormalities
- Poor blood pressure control in the past month
- Brain, spinal, or eye surgery (excluding cataract surgery) within three months before screening
- Bleeding disorders or history increasing bleeding risk
- Abnormal blood pressure readings during screening
- Significant heart rhythm abnormalities or conduction issues on ECG
- History of drug or alcohol abuse within one year before screening
- Allergy to the study drug or similar substances
- Active infections including HIV, syphilis, active hepatitis B or C
- Participation in another clinical trial with drug treatment within three months before screening
- Planned kidney transplant during the study or within three months after
- Inability to avoid xanthine, coffee, or alcohol during the study
- Any medical condition that may interfere with the study drug, affect data, or pose safety risks as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks
Participants receive the study drug KN060 administered via the dialysis line during their regular hemodialysis sessions.
Three visits per week during hemodialysis sessions
Duration - Up to 18 weeks
Participants are monitored for safety, pharmacokinetics, pharmacodynamics, and potential side effects after completing treatment.
Visits aligned with dialysis sessions as needed for assessments
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
Y
Yanrong Dong, Master
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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