MedTrace Logo

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

NCT07201467 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-10-01

No results posted yet for this study

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.

Conditions

  • End-Stage Renal Disease Requiring Haemodialysis

Interventions

DRUG

KN060

pharmacokinetic and pharmacodynamic characteristics of KN060 in ESRD on Hemodialysis

Sponsors & Collaborators

  • Suzhou Alphamab Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Li Zuo, Doctor · Peking University People's Hospital

  • Yuqing Chen · Peking University First Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-22
Primary Completion
2027-08-15
Completion
2027-12-15

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07201467 on ClinicalTrials.gov