A Clinical Study to Evaluate the Efficacy, Safety and PK/PD Profiles of Anticoagulation of HSK36273 for Injection in Continuous Renal Replacement Therapy Subjects

A Multi-center, Randomized, Open, Positive-controlled Two-stage Phase II Clinical Study to Evaluate the Efficacy, Safety and PK/PD Profiles of Anticoagulation of HSK36273 for Injection in Continuous Renal Replacement Therapy Subjects

This study is divided into Stage I and Stage II. It is planned to include 156 subjects who need CRRT treatment for more than 48 hours.

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Replacement Therapy
• Intervention / Treatment: Drug: HSK36273; Drug: Heparin sodium

• Study Type: Interventional
• Enrollment (Anticipated): 156
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • The First Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female aged ≥18 and ≤80;
2. 16 kg/m2 ≤BMI≤35 kg/m2;
3. Those who need CRRT treatment for more than 48 hours and plan to use CVVHDF treatment mode for femoral vein puncture;
4. Subjects or their guardians voluntarily sign the informed consent form in writing before any procedure related to the study starts, fully understand the purpose and significance of this trial, and are willing to comply with the trial protocol.

Exclusion Criteria:

1. Those who are known to be allergic to heparin, heparin drugs, investigational drugs or non-active ingredients of study intervention;
2. Subjects with severe coagulation dysfunction or bleeding tendency three months before the screening, such as HIT (heparin-induced thrombocytopenia), ITP (idiopathic thrombocytopenia purpura), TTP (thrombocytopenia purpura), persistent systolic blood pressure>200 mmHg or diastolic blood pressure>120 mmHg, active gastrointestinal bleeding, intracranial hemorrhage, cerebral aneurysm, severe retinopathy bleeding, hemophilia, hemolytic uremic syndrome, stroke, acute coronary syndrome;
3. Those who have undergone major cardiac surgery or craniocerebral surgery within 3 months before screening and who are judged by the study doctor to be at risk of serious bleeding;
4. Those whose platelet ≤ 50*109/L and/or INR>1.8 and/or aPTT>55s at screening;
5. Those who need to combine other blood purification methods such as blood perfusion or ECMO;
6. The time from the point of randomization to the last use of anticoagulants (low-molecular-weight heparin, warfarin, apixaban, bivalirudin, etc.), antiplatelet drugs (clopidogrel, aspirin, etc.), fibrinolytic drugs (urokinase, etc.) is shorter than the 5 half-lives of the drug or the duration of drug efficacy (calculated by the longest time);
7. The time of administration is shorter than 1 half-life of low-molecular-weight heparin from the last preventive dose;
8. Child-Pugh liver function is grade C in screening period;
9. Those with positive hepatitis C antibody or HIV antibody screening;
10. Pregnant and lactating women; women or men with fertility are unwilling to use contraception throughout the study period; subjects with pregnancy plans within 6 months after the study (including male subjects);
11. Those who have participated in clinical trials of other drugs within 3 months before screening (defined as having received investigational drug or placebo);
12. Other conditions that the investigator judges are not suitable for the subject to participate in the clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HSK36273 Continuous infusion; Drug:HSK36273 Administration mode:Continuous infusion	Drug: HSK36273; HSK36273
EXPERIMENTAL: HSK36273 Bolus+Continuous infusion; Drug:HSK36273 Administration mode:Bolus+Continuous infusion	Drug: HSK36273; HSK36273
ACTIVE_COMPARATOR: Heparin sodium; Drug:Heparin sodium Administration mode:Bolus+Continuous infusion	Drug: Heparin sodium; Heparin sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Filter life	the time from the start of administration to the first filter replacement and the average filter using time during the treatment period	Day1 to Day5
Times of filter replacement	the times of filter replacement within 120h after starting administration	Day1 to Day5
Coagulation grade of filter and pipeline	Clotting in the dialyser and the air traps as evaluated by a scale from 0 to 3	Day1 to Day5

Collaborators and Investigators

• Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2022
• Primary Completion (ANTICIPATED): October 1, 2023
• Study Completion (ANTICIPATED): October 1, 2023

Study Registration Dates

• First Submitted: October 16, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (ACTUAL): November 1, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Renal Replacement Therapy; Anticoagulants
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: HSK36273-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No