Renal Replacement TherapyPhase 2NCT05602129

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 Phase 2 study testing HSK36273 and Heparin sodium in people with Renal Replacement Therapy, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Renal Replacement Therapy
What is being tested?: HSK36273 and Heparin sodium
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 156 participants
Where: 1 siteChina
Study dates: Nov 2022to Oct 2023
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female aged ≥18 and ≤80;
16 kg/m2 ≤BMI≤35 kg/m2;
Those who need CRRT treatment for more than 48 hours and plan to use CVVHDF treatment mode for femoral vein puncture;
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.

Who cannot join

Those who are known to be allergic to heparin, heparin drugs, investigational drugs or non-active ingredients of study intervention;
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;
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;
Those whose platelet ≤ 50*109/L and/or INR>1.8 and/or aPTT>55s at screening;
Those who need to combine other blood purification methods such as blood perfusion or ECMO;
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);

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The time of administration is shorter than 1 half-life of low-molecular-weight heparin from the last preventive dose;
Child-Pugh liver function is grade C in screening period;
Those with positive hepatitis C antibody or HIV antibody screening;
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);
Those who have participated in clinical trials of other drugs within 3 months before screening (defined as having received investigational drug or placebo);
Other conditions that the investigator judges are not suitable for the subject to participate in the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Sun Yat-sen University
Guangzhou

Other trials in China

About this study

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

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.

Conditions: Renal Replacement Therapy
Being tested: HSK36273, Heparin sodium
Keywords: Renal Replacement Therapy, Anticoagulants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HSK36273Drug
HSK36273
Heparin sodiumDrug
Heparin sodium

Study groups in NCT05602129
Study group	Role	What they receive
HSK36273 Continuous infusion	Experimental	Drug:HSK36273 Administration mode:Continuous infusion Receives: Drug: HSK36273
HSK36273 Bolus+Continuous infusion	Experimental	Drug:HSK36273 Administration mode:Bolus+Continuous infusion Receives: Drug: HSK36273
Heparin sodium	Active comparator	Drug:Heparin sodium Administration mode:Bolus+Continuous infusion Receives: Drug: Heparin sodium

What is being measured

The primary outcome is the main question the study is designed to answer.

Filter life
the time from the start of administration to the first filter replacement and the average filter using time during the treatment period
Measured: Day1 to Day5
Times of filter replacement
the times of filter replacement within 120h after starting administration
Measured: 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
Measured: Day1 to Day5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2022Oct 2023

First posted1 Nov 2022
Study startNov 2022 (estimated)
Primary completionOct 2023 (estimated)
Study completionOct 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal Replacement TherapyStudies of the same condition, open and under way.
More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 156 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05602129
Sponsor's protocol ID: HSK36273-201
Status last verified: Nov 2022
First submitted: 16 Oct 2022
Last updated: 2 Nov 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Renal Replacement Therapy trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05602129
Acronym / sponsor ID: HSK36273-201
Conditions: Renal Replacement Therapy
Keywords: Renal Replacement Therapy, Anticoagulants
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 156 participants (estimated)
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
Study start: Nov 2022 (estimated)
Primary completion: Oct 2023 (estimated)
Study completion: Oct 2023 (estimated)
First posted: 1 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
HSK36273 Continuous infusion	Experimental	Drug: HSK36273Drug:HSK36273 Administration mode:Continuous infusion
HSK36273 Bolus+Continuous infusion	Experimental	Drug: HSK36273Drug:HSK36273 Administration mode:Bolus+Continuous infusion
Heparin sodium	Active comparator	Drug: Heparin sodiumDrug:Heparin sodium Administration mode:Bolus+Continuous infusion

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female aged ≥18 and ≤80;
16 kg/m2 ≤BMI≤35 kg/m2;
Those who need CRRT treatment for more than 48 hours and plan to use CVVHDF treatment mode for femoral vein puncture;
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.

Key exclusion criteria (12 listed)

Those who are known to be allergic to heparin, heparin drugs, investigational drugs or non-active ingredients of study intervention;
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;
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;
Those whose platelet ≤ 50*109/L and/or INR>1.8 and/or aPTT>55s at screening;
Those who need to combine other blood purification methods such as blood perfusion or ECMO;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HSK36273HSK36273	Drug	HSK36273 Bolus+Continuous infusion, HSK36273 Continuous infusion
Heparin sodiumHeparin sodium	Drug	Heparin sodium

Primary outcome

Filter life
Time frame: 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
Times of filter replacement
Time frame: Day1 to Day5
the times of filter replacement within 120h after starting administration
Coagulation grade of filter and pipeline
Time frame: Day1 to Day5
Clotting in the dialyser and the air traps as evaluated by a scale from 0 to 3

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
Individual participant dataSharing planned: No

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Recruiting
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Pharmacokinetics and Optimal Dosing of Levetiracetam in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
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Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HSK36273 and Heparin sodium in people with Renal Replacement Therapy, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Filter life (time frame: Day1 to Day5). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05602129.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.