Study of KN060 Safety and Effects in Adults with End-Stage Renal Disease on Regular Hemodialysis

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 mgkg 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 drugs effects and tolerability.

To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN060 in ESRD Dialysis Patients