NCT07201467 To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN060 in ESRD Dialysis Patients
| NCT ID | NCT07201467 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Suzhou Alphamab Co., Ltd. |
| Condition | End-Stage Renal Disease Requiring Haemodialysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-08-22 |
| Primary Completion | 2027-08-15 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
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 par