Chronic Kidney Disease PatientsPhase 1NCT06238388
Metabolism and Excretory of HSK21542 in Maintenance Hemodialysis Patients
A Phase 1 study testing HSK21542 Injection in people with Chronic Kidney Disease Patients, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, nonrandomized, and open design study to investigate metabolism and excretion of HSK21542 in maintenance hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Patients
- What is being tested?
- HSK21542 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2023to 27 Feb 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are willing to sign an informed consent form, fully understand the objectives and purposes of the study, and are willing to comply with the study protocol before any of the study-related procedures start.
- Age ≥18 years old, Male or female;
- Patients with end-stage renal diseases who receive hemodialysis (including hemodiafiltration) 3 times in a week prior to screening for at least 3 months;
- Dry weight is 40.0-135.0 kg (inclusive) during the screening period;
- Patients with at least two occurrences of single-compartment urea clearance (sp Kt/V) ≥ 1.2, or at least two occurrences of urea reduction ratio (URR) ≥ 65%, or one occurrence of sp Kt/V ≥ 1.2 and one occurrence of URR ≥ 65% on different days of dialysis within 6 months before administration;
- Female of childbearing age or Male must agree to adopt efficient contraceptive measures in sexual intercourse during the study period and within 3 months after the last administration; Menopausal female subjects should have had menopause at least one year or should have had permanent sterilization (e.g., fallopian tube occlusion, hysterectomy, bilateral salpingectomy).
Who cannot join
- Expected to undergo kidney transplantation and/or parathyroidectomy during the study;
- History of allergy to opioids, such as urticaria (Note: adverse effects related to opioid use, such as constipation and nausea, are not included as the exclusion criteria in this study);
- Used opioids within 7 days before screening, or unable to avoid the use of opioids other than the investigational product during the study;
- Participated in any clinical trial of other drug or medical device within 1 month before screening (received study medication or treated by the medical device in the clinical trial);
- Used blood perfusion during the screening period or expected study period;
- Blood pressure of upper limbs in the supine position at screening: systolic blood pressure < 90 mmHg, or diastolic blood pressure < 60 mmHg, or systolic blood pressure > 180 mmHg, or diastolic blood pressure > 110 mmHg;
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- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)≥ 2.5 × upper limit of normal (ULN), or total bilirubin ≥ 2 × upper limit of normal (ULN) at screening;
- Blood sodium > 155 mmol/L at screening;
- Blood donation (or loss) ≥ 400 mL within the first 3 months of screening or Hemoglobin < 80 g/L at screening;
- Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody;
- Females who are pregnant or breastfeeding;
- Smoking an average of more than 5 cigarettes per day within the first 3 months of screening, or not stopping the use of any tobacco products during the trial period;
- Any physiological or psychological diseases or conditions that may increase the risk of the trial, affect the subject's compliance with the protocol, or affect the subject's completion of the trial, as judged by the study physician, including but not limited to:
- Known or suspected alcohol, anesthetic, or other substance abuse or drug dependence history within the first 12 months of screening; Baseline urine drug screening (if any) or positive alcohol breath test;
- severe systolic or diastolic heart failure within the first 6 months of screening (e.g. NYHA grade IV congestive heart failure (NYHA heart function grading criteria can be found in Appendix 3) ;
- Severe mental illness or cognitive impairment (e.g., dementia);
- Any other relevant acute or chronic neurological and psychiatric diseases (e.g., encephalopathy, coma, delirium) within 3 months before screening And the researchers believe it is not suitable for enrollment;
- Patients with malignant tumors, but not including: curable cervical carcinoma in situ, skin basal cell carcinoma, or squamous cell carcinoma, or any other tumor that has been cured (with no evidence of disease recurrence within 5 years).
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong
About this study
Official title: A Phase I Clinical Trial Exploring the Metabolic and Excretion Characteristics of HSK21542 Injection in Maintenance Hemodialysis Patients
This is a single-center, nonrandomized, and open design study to investigate metabolism and excretion of HSK21542 in maintenance hemodialysis patients.
- Conditions
- Chronic Kidney Disease Patients
- Being tested
- HSK21542 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK21542 InjectionDrug
A single intravenous dose of 0.8 μg/kg HSK21542 in boluses after D1 dialysis completed.
| Study group | Role | What they receive |
|---|---|---|
| 0.8 μg/kg HSK21542 Injection | Experimental | 0.8 μg/kg HSK21542 Injection Receives: Drug: HSK21542 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative recovery of unchanged drug (Ae)
The pharmacokinetic parameters of HSK21542 in urine, feces, and dialysate
Measured: From the start of administration to 168 hours after administration
Cumulative recovery fraction of unchanged drug (Fe)
The pharmacokinetic parameters of HSK21542 in urine, feces, and dialysate
Measured: From the start of administration to 168 hours after administration
Plasma clearance
The pharmacokinetic parameters of HSK21542 in urine, feces, and dialysate
Measured: From the start of administration to 168 hours after administration
Cmax
The pharmacokinetic parameters of HSK21542 in plasma
Measured: From the start of administration to 168 hours after administration
AUC(0-t)
The pharmacokinetic parameters of HSK21542 in plasma
Measured: From the start of administration to 168 hours after administration
AUC(0-∞)
The pharmacokinetic parameters of HSK21542 in plasma
Measured: From the start of administration to 168 hours after administration
Tmax
The pharmacokinetic parameters of HSK21542 in plasma
Measured: From the start of administration to 168 hours after administration
t1/2
The pharmacokinetic parameters of HSK21542 in plasma
Measured: From the start of administration to 168 hours after administration
Secondary outcomes (2)
The main metabolites of HSK21542
The main metabolites of HSK21542 in plasma, urine, feces, and dialysate
Measured: From the start of administration to 168 hours after administration
Adverse events (AEs)
The incidence and severity of AEs
Measured: From after administration to the end of telephone follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start10 Oct 2023
- Primary completion21 Nov 2023
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease PatientsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238388
- Sponsor's protocol ID
- HSK21542-105
- Status last verified
- Aug 2024
- First submitted
- 21 Jan 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial Exploring the Metabolic and Excretion Characteristics of HSK21542 Injection in Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06238388
- Acronym / sponsor ID
- HSK21542-105
- Conditions
- Chronic Kidney Disease Patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 2 Feb 2024 (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 is a single-center, nonrandomized, and open design study to investigate metabolism and excretion of HSK21542 in maintenance hemodialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0.8 μg/kg HSK21542 Injection | Experimental | Drug: HSK21542 Injection0.8 μg/kg HSK21542 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who are willing to sign an informed consent form, fully understand the objectives and purposes of the study, and are willing to comply with the study protocol before any of the study-related procedures start.
- Age ≥18 years old, Male or female;
- Patients with end-stage renal diseases who receive hemodialysis (including hemodiafiltration) 3 times in a week prior to screening for at least 3 months;
- Dry weight is 40.0-135.0 kg (inclusive) during the screening period;
- Patients with at least two occurrences of single-compartment urea clearance (sp Kt/V) ≥ 1.2, or at least two occurrences of urea reduction ratio (URR) ≥ 65%, or one occurrence of sp Kt/V ≥ 1.2 and one occurrence of URR ≥ 65% on different days of dialysis within 6 months before administration;
Key exclusion criteria (18 listed)
- Expected to undergo kidney transplantation and/or parathyroidectomy during the study;
- History of allergy to opioids, such as urticaria (Note: adverse effects related to opioid use, such as constipation and nausea, are not included as the exclusion criteria in this study);
- Used opioids within 7 days before screening, or unable to avoid the use of opioids other than the investigational product during the study;
- Participated in any clinical trial of other drug or medical device within 1 month before screening (received study medication or treated by the medical device in the clinical trial);
- Used blood perfusion during the screening period or expected study period;
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 |
|---|---|---|
| HSK21542 InjectionA single intravenous dose of 0.8 μg/kg HSK21542 in boluses after D1 dialysis completed. | Drug | 0.8 μg/kg HSK21542 Injection |
Primary outcome
Cumulative recovery of unchanged drug (Ae)
Time frame: From the start of administration to 168 hours after administration
The pharmacokinetic parameters of HSK21542 in urine, feces, and dialysate
Cumulative recovery fraction of unchanged drug (Fe)
Time frame: From the start of administration to 168 hours after administration
The pharmacokinetic parameters of HSK21542 in urine, feces, and dialysate
Plasma clearance
Time frame: From the start of administration to 168 hours after administration
The pharmacokinetic parameters of HSK21542 in urine, feces, and dialysate
Cmax
Time frame: From the start of administration to 168 hours after administration
The pharmacokinetic parameters of HSK21542 in plasma
AUC(0-t)
Time frame: From the start of administration to 168 hours after administration
The pharmacokinetic parameters of HSK21542 in plasma
AUC(0-∞)
Time frame: From the start of administration to 168 hours after administration
The pharmacokinetic parameters of HSK21542 in plasma
Tmax
Time frame: From the start of administration to 168 hours after administration
The pharmacokinetic parameters of HSK21542 in plasma
t1/2
Time frame: From the start of administration to 168 hours after administration
The pharmacokinetic parameters of HSK21542 in plasma
2 secondary outcomes
The main metabolites of HSK21542
Time frame: From the start of administration to 168 hours after administration
Adverse events (AEs)
Time frame: From after administration to the end of telephone follow-up
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 20 Aug 2024.
- Individual participant dataSharing planned: No
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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 HSK21542 Injection in people with Chronic Kidney Disease Patients, 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 6 inclusion and 18 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 20 Aug 2024. 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?
Cumulative recovery of unchanged drug (Ae) (time frame: From the start of administration to 168 hours after administration). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2024.