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

ConditionEnd-Stage Renal Disease Requiring Haemodialysis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSuzhou Alphamab Co., Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Male or female subjects aged between 18 and 80 years (inclusive);

1 8 kg /m ² <BMI <2 8 kg /m² ;

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) ;

The clinical status of the underlying ESRD is stable (assessed by the investigator) ;

Disqualifiers

A history of malignant tumor;

History of mechanical/artificial heart valve replacement surgery;

History of major medical events within 3 months before screening , such as acute coronary syndrome, stroke , major organ bleeding, acute heart failure, systemic thromboembolic events , major surgery, etc. , or history of AVF/AVG functional loss;

Using anticoagulant/antiplatelet drugs due to disease treatment , such as warfarin , dabigatran, rivaroxaban , clopidogrel , or aspirin >100 mg/day (investigators are allowed to use heparin / low molecular weight heparin during dialysis, depending on the situation );

Trial design

Design model

Single group

Treatments tested in this trial

  • KN060

    Drug

    pharmacokinetic and pharmacodynamic characteristics of KN060 in ESRD on Hemodialysis

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: KN060Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety Results

Number, frequency, incidence and severity of treatment-emergent adverse events (TEAEs), drug-related adverse events (TRAEs), adverse events of special interest (AESIs), serious adverse events (SAEs), etc.

Time frame
up to 18 weeks

Secondary outcomes

1

Pharmacokinetics characteristics

Trough blood concentration after reaching stability (C min,ss )

Time frame
up to 18 weeks
2

Pharmacodynamic characteristics

Pharmacodynamic characteristics after multiple administrations, pharmacodynamic indicators include: total coagulation factor XI ( Total FXI ), free FXI ( Free FXI ), activated partial thromboplastin time ( APTT ) and FXI activity; After the blood drug concentration reached a stable level, the occurrence of achieving \>50% or 95% inhibition of FXI;

Time frame
up to 18 weeks
3

Immunogenicity Results

The number and ratio of patients who produced anti-KN060 antibodies (ADA); the number and ratio of patients who produced anti-KN060 neutralizing antibodies (NAb) (NAb testing will be performed only on ADA-positive samples)

Time frame
up to 18 weeks
4

Bleeding Events

Number, frequency, and incidence of major bleeding events, clinically relevant non-major bleeding (CRNM) events, and all bleeding events;

Time frame
up to 18 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Alphamab Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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