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

Renal Replacement Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05602129
• Other study ID #: HSK36273-201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 2022
• Est. completion date: October 2023

Study information

• Verified date: November 2022
• Source: Haisco Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 156
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Replacement Therapy

Intervention

Drug:
• HSK36273
HSK36273
• Heparin sodium
Heparin sodium

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Haisco Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Times of filter replacement	the times of filter replacement within 120h after starting administration	Day1 to Day5
Primary	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