Chronic Renal ImpairmentPhase 1NCT04142970
Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Patients With Impairment Renal Functions
A Phase 1 study testing HSK3486 in people with Chronic Renal Impairment, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 1 site in China.
Trial summary
A Clinical Study Comparatively Evaluating the Pharmacokinetics, Pharmacodynamics and Safety of Intravenous Administration of HSK3486 Injectable Emulsion in Patients with Chronic Renal Impairment and Subjects with Normal Renal Functions Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Impairment
- What is being tested?
- HSK3486
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2020to 18 Aug 2020
- Phase
- Phase 1
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females with full capacity for civil conduct, aged ≥ 18 and < 65 years old;
- Weighing ≥ 45 kg, and with a body mass index (BMI) of ≥ 18 and ≤ 28 kg/ m^2(BMI = weight (kg)/height2 ( m^2));
- For matched subjects with normal renal functions: physical examination, laboratory tests (blood routine, blood biochemistry, urine routine, urinary albumin/creatinine ratio, creatine kinase (CK) and coagulation function), and 12-lead ECG, etc. should be normal or abnormal without clinical significance as determined by the investigator;
- No potential difficult airway (modified Mallampati score of Grade I to II);
- For matched subjects with normal renal functions: no history of major organ primary diseases, such as liver, kidneys, digestive tract, blood, and metabolic diseases; no history of malignant hyperthermia and other genetic conditions; no history of mental/neurological diseases; no history of epilepsy; no contraindications for deep sedation/general anesthesia; no clinically significant history of anesthesia accidents;
- Subjects must understand the procedures and methods of this study, and be willing to signing the informed consent form and to complete the trial in strict accordance with clinical trial protocol;
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- Patients with Renal Impairment Must Also Meet the Following Criteria:
- The estimated glomerular filtration rate (eGFR) of the subjects in corresponding groups meets the criteria for mild to moderate renal impairment in the staging of renal functions, i.e., mild renal impairment: 60-89 mL/min/1.73 m^2; moderate renal impairment: 30-59 mL/min/1.73 m^2; subjects with normal renal functions: ≥ 90 mL/min/1.73 m^2;
- For subjects with renal impairment, their laboratory test results (coagulation function, blood routine, urinary albumin/creatinine ratio, creatine kinase (CK), blood biochemistry, and urine routine) should be judged by the investigators as clinically stable and consistent with the severity of their renal impairment. In addition, their albumin should be > 35 g/L and hemoglobin should be > 110 g/L;
- Exclusion Criteria( those who meet any one of the followings are ineligible):
- Known sensitivity to excipients in HSK3486 injectable emulsion (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate and sodium hydroxide); history of drug allergies (including other anesthetics);
- Received any one of the following medications or treatments prior to screening/enrollment:
- History of drug abuse or any signs of long-term use of benzodiazepines (such as insomnia, anxiety, spasms) within 3 months prior to screening; Participated in clinical trials involving any medications or medical devices within 3 months prior to screening, or subjects who have participated in 3 or more drug clinical trials within the past year; Serious infection, trauma, or major surgery within 4 weeks before screening; or acute disease with clinical significance (determined by the investigators) within 2 weeks before screening, including GI diseases or infections (such as respiratory tract or CNS infections); In receipt of propofol, other sedatives/anesthetics and/or opioid analgesics or compounds containing analgesics within 72 hrs prior to baseline; Used potent inhibitors of CYP enzyme within 7 days prior to enrollment, or used moderate/low potency inhibitors of CYP enzyme within 3 days prior to enrollment;
- History or evidence of any one of the following diseases prior to screening/enrollment:
- History of cardiovascular diseases such as: uncontrolled hypertension [SBP ≥ 170 mmHg and/or DBP ≥ 105 without antihypertensive treatment, or SBP > 160 mmHg and/or DBP > 100 mmHg despite antihypertensive treatment], postural hypotension, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction within 6 months before screening, history of tachycardia/bradycardia requiring medication, II-III degree atrioventricular block (excluding patients with pacemakers) or QTcF interval ≥ 450 ms (Fridericia's correction formula); Respiratory insufficiency, history of obstructive pulmonary disease, history of asthma, sleep apnea; history of failed tracheal intubation; history of bronchospasm requiring treatment within 3 months prior to screening; acute respiratory infection, and with obvious symptoms such as fever, wheezing, nasal congestion or cough within 1 week prior to baseline; History of gastrointestinal diseases: History of gastrointestinal retention, moderate and above active bleeding (GUSTO bleeding classification), gastroesophageal reflux that may lead to aspiration; [Note: GUSTO bleeding classification is: heavy or life-threatening bleeding (intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention), moderate bleeding (requires blood transfusion but does not cause hemodynamic compromise), minor bleeding (does not meet the criteria for either severe or moderate bleeding)]; History of cerebrovascular diseases: history of craniocerebral injury, possible convulsions, intracranial hypertension, cerebral aneurysm, or cerebrovascular accident; History of mental illness: schizophrenia, mania, chronic use of antipsychotics, or cognitive impairment;
- Positive test for either HBsAg, HCV, HIV, or syphilis;
- History of alcohol abuse within 3 months prior to screening, alcohol abuse defined as average of > 2 units of alcohol per day (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine), or positive alcohol breath test results at baseline;
- Smoke more than 5 cigarettes per day and a total of more than 60 cigarettes within 3 months prior to screening;
- Blood donation or blood loss ≥ 200 mL within 30 days prior to screening; plasma donation or plasma exchange within 7 days prior to screening;
- Subjects who have consumed any beverages or foods containing alcohol, grapefruit juice or methylxanthine (such as coffee, tea, cola, chocolate, and functional drinks), participated in strenuous physical activities and other factors that may affect drug absorption, distribution, metabolism, and excretion within 2 days prior to baseline; subjects who are unable to fast for 8 hrs before dose administration;
- Subjects expected to have surgery or hospitalization during the trial;
- Subjects unsuitable for arterial blood collection, such as subjects who have positive Allen's test results;
- Other than the disease diagnosed as renal impairment, patients with acute illnesses in any other organ, as well as those with chronic conditions that may affect the in vivo process of the investigational drug (e.g., chronic hepatitis, hepatic insufficiency, etc.);
- Patients with autoimmune nephropathy, obstructive nephropathy, history of kidney transplantation, and an ongoing dialysis treatment.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: A Clinical Study Comparatively Evaluating the Pharmacokinetics, Pharmacodynamics and Safety of Intravenous Administration of HSK3486 Injectable Emulsion in Patients With Chronic Renal Impairment and Subjects With Normal Renal Functions
A Clinical Study Comparatively Evaluating the Pharmacokinetics, Pharmacodynamics and Safety of Intravenous Administration of HSK3486 Injectable Emulsion in Patients with Chronic Renal Impairment and Subjects with Normal Renal Functions
Read the detailed description
This is a single-center, open-label, non-randomized, parallel-controlled Phase I clinical study carried out in subjects with varying degrees (mild or moderate) of renal impairment, and age-, weight-, and gender-matched subjects with normal renal functions.
- Conditions
- Chronic Renal Impairment
- Being tested
- HSK3486
- Keywords
- Mild renal impairment, Moderate renal impairment
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK3486Drug
HSK3486，Initially 0.4 mg/kg was administered as a 1 minute bolus, followed immediately by a constant infusion dose of 0.4 mg/kg/h administered as a 30 minute infusion via infusion pump.
| Study group | Role | What they receive |
|---|---|---|
| Mild renal impairment | Active comparator | Mild renal impairment (eGFR: 60-89 mL/min/1.73 m^2) Receives: Drug: HSK3486 |
| Moderate renal impairment | Active comparator | Moderate renal impairment (eGFR: 30-59 mL/min/1.73 m^2) Receives: Drug: HSK3486 |
| Subjects with normal renal functions | Active comparator | Subjects with normal renal functions (eGFR: ≥ 90 mL/min/1.73 m^2) Receives: Drug: HSK3486 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration (Cmax)
Cmax（a measure of the body's exposure to HSK3486）will be compared between normal renal function patients and mild or moderate chronic renal impairment patients .
Measured: -30 minutes before administration until 24 hours post administration on day 1
Area under the concentration-time curve（AUC）
AUC（a measure of the body's exposure to HSK3486）will be compared between normal renal function patients and mild or moderate chronic renal impairment patients .
Measured: -30 minutes before administration until 24 hours post administration on day 1
Secondary outcomes (6)
MOAA/S(modified observer's assessment of alert /sedation)
Measured: -5 minutes before administration until 1 hours post administration on day 1
Bispectral index(BIS)
Measured: -5 minutes before administration until 1 hours post administration on day 1
Tmax
time to peak observed
Measured: -30 minutes before administration until 24 hours post administration on day 1
Total clearance
Measured: -30 minutes before administration until 24 hours post administration on day 1
Volume of distribution
Measured: -30 minutes before administration until 24 hours post administration on day 1
blood pressure（systolic, diastolic and mean arterial pressure）
safety endpoits
Measured: from the screening to 3 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start5 Jan 2020
- Primary completion4 Aug 2020
- Study completion18 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal ImpairmentStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142970
- Sponsor's protocol ID
- HSK3486-106
- Status last verified
- Dec 2020
- First submitted
- 24 Oct 2019
- Last updated
- 19 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tao J, Liu S, Zhao YY, Qi L, Yan P, Wu N, Liu X, Liu D, Tian X. Pharmacokinetics, pharmacodynamics, and safety of ciprofol emulsion in Chinese subjects with normal or impaired renal function. Front Pharmacol. 2023 Nov 23;14:1260599. doi: 10.3389/fphar.2023.1260599. eCollection 2023.
PubMed 38074142
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Comparatively Evaluating the Pharmacokinetics, Pharmacodynamics and Safety of Intravenous Administration of HSK3486 Injectable Emulsion in Patients With Chronic Renal Impairment and Subjects With Normal Renal Functions
- ClinicalTrials.gov ID
- NCT04142970
- Acronym / sponsor ID
- HSK3486-106
- Conditions
- Chronic Renal Impairment
- Keywords
- Mild renal impairment, Moderate renal impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Zhengzhou University
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 4 Aug 2020 (actual)
- Study completion
- 18 Aug 2020 (actual)
- First posted
- 29 Oct 2019 (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.
A Clinical Study Comparatively Evaluating the Pharmacokinetics, Pharmacodynamics and Safety of Intravenous Administration of HSK3486 Injectable Emulsion in Patients with Chronic Renal Impairment and Subjects with Normal Renal Functions
Detailed description
This is a single-center, open-label, non-randomized, parallel-controlled Phase I clinical study carried out in subjects with varying degrees (mild or moderate) of renal impairment, and age-, weight-, and gender-matched subjects with normal renal functions.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild renal impairment | Active comparator | Drug: HSK3486Mild renal impairment (eGFR: 60-89 mL/min/1.73 m^2) |
| Moderate renal impairment | Active comparator | Drug: HSK3486Moderate renal impairment (eGFR: 30-59 mL/min/1.73 m^2) |
| Subjects with normal renal functions | Active comparator | Drug: HSK3486Subjects with normal renal functions (eGFR: ≥ 90 mL/min/1.73 m^2) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- Males or females with full capacity for civil conduct, aged ≥ 18 and < 65 years old;
- Weighing ≥ 45 kg, and with a body mass index (BMI) of ≥ 18 and ≤ 28 kg/ m^2(BMI = weight (kg)/height2 ( m^2));
- For matched subjects with normal renal functions: physical examination, laboratory tests (blood routine, blood biochemistry, urine routine, urinary albumin/creatinine ratio, creatine kinase (CK) and coagulation function), and 12-lead ECG, etc. should be normal or abnormal without clinical significance as determined by the investigator;
- No potential difficult airway (modified Mallampati score of Grade I to II);
- For matched subjects with normal renal functions: no history of major organ primary diseases, such as liver, kidneys, digestive tract, blood, and metabolic diseases; no history of malignant hyperthermia and other genetic conditions; no history of mental/neurological diseases; no history of epilepsy; no contraindications for deep sedation/general anesthesia; no clinically significant history of anesthesia accidents;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| HSK3486HSK3486，Initially 0.4 mg/kg was administered as a 1 minute bolus, followed immediately by a constant infusion dose of 0.4 mg/kg/h administered as a 30 minute infusion via infusion pump. | Drug | Mild renal impairment, Moderate renal impairment, Subjects with normal renal functions |
Primary outcome
Peak concentration (Cmax)
Time frame: -30 minutes before administration until 24 hours post administration on day 1
Cmax（a measure of the body's exposure to HSK3486）will be compared between normal renal function patients and mild or moderate chronic renal impairment patients .
Area under the concentration-time curve（AUC）
Time frame: -30 minutes before administration until 24 hours post administration on day 1
AUC（a measure of the body's exposure to HSK3486）will be compared between normal renal function patients and mild or moderate chronic renal impairment patients .
6 secondary outcomes
MOAA/S(modified observer's assessment of alert /sedation)
Time frame: -5 minutes before administration until 1 hours post administration on day 1
Bispectral index(BIS)
Time frame: -5 minutes before administration until 1 hours post administration on day 1
Tmax
Time frame: -30 minutes before administration until 24 hours post administration on day 1
Total clearance
Time frame: -30 minutes before administration until 24 hours post administration on day 1
Volume of distribution
Time frame: -30 minutes before administration until 24 hours post administration on day 1
blood pressure（systolic, diastolic and mean arterial pressure）
Time frame: from the screening to 3 days post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Derived from this study: PubMed 38074142Tao J, Liu S, Zhao YY, Qi L, Yan P, Wu N, Liu X, Liu D, Tian X. Pharmacokinetics, pharmacodynamics, and safety of ciprofol emulsion in Chinese subjects with normal or impaired renal function. Front Pharmacol. 2023 Nov 23;14:1260599. doi: 10.3389/fphar.2023.1260599. eCollection 2023.
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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 1 study testing HSK3486 in people with Chronic Renal Impairment, run by Sichuan 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 24 inclusion and 0 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: finished, as of the sponsor's last update on 19 Dec 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peak concentration (Cmax) (time frame: -30 minutes before administration until 24 hours post administration on day 1). The study lists 2 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 NCT04142970, which also lists 1 linked publication.
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 19 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.