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

• Sponsor: Haisco Pharmaceutical Group Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05602129
• Collaborator: (none)
• Enrollment: 156
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 11
• Patients Per Site Per Month: 14.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Renal Replacement Therapy	Drug: HSK36273; Drug: Heparin sodium	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 156 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Filter life [Day1 to Day5]

   the time from the start of administration to the first filter replacement and the average filter using time during the treatment period

2. Times of filter replacement [Day1 to Day5]

   the times of filter replacement within 120h after starting administration

3. Coagulation grade of filter and pipeline [Day1 to Day5]

   Clotting in the dialyser and the air traps as evaluated by a scale from 0 to 3

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou		China

Sponsors and Collaborators

• Haisco Pharmaceutical Group Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haisco Pharmaceutical Group Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05602129
• Other Study ID Numbers: HSK36273-201
• First Posted: Nov 1, 2022
• Last Update Posted: Nov 2, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Haisco Pharmaceutical Group Co., Ltd.: Renal Replacement Therapy; Anticoagulants
• Additional relevant MeSH terms: Heparin; Calcium heparin

Study Results

No Results Posted as of Nov 2, 2022