Chronic Kidney Disease Patients
Conditions
Brief summary
This is a single-center, nonrandomized, and open design study to investigate metabolism and excretion of HSK21542 in maintenance hemodialysis patients.
Interventions
A single intravenous dose of 0.8 μg/kg HSK21542 in boluses after D1 dialysis completed.
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Age ≥18 years old, Male or female; 3. Patients with end-stage renal diseases who receive hemodialysis (including hemodiafiltration) 3 times in a week prior to screening for at least 3 months; 4. Dry weight is 40.0-135.0 kg (inclusive) during the screening period; 5. 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; 6. 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).
Exclusion criteria
1. Expected to undergo kidney transplantation and/or parathyroidectomy during the study; 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| t1/2 | From the start of administration to 168 hours after administration | The pharmacokinetic parameters of HSK21542 in plasma |
| AUC(0-∞) | From the start of administration to 168 hours after administration | The pharmacokinetic parameters of HSK21542 in plasma |
| Tmax | From the start of administration to 168 hours after administration | The pharmacokinetic parameters of HSK21542 in plasma |
| Cumulative recovery of unchanged drug (Ae) | 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) | From the start of administration to 168 hours after administration | The pharmacokinetic parameters of HSK21542 in urine, feces, and dialysate |
| Plasma clearance | From the start of administration to 168 hours after administration | The pharmacokinetic parameters of HSK21542 in urine, feces, and dialysate |
| Cmax | From the start of administration to 168 hours after administration | The pharmacokinetic parameters of HSK21542 in plasma |
| AUC(0-t) | From the start of administration to 168 hours after administration | The pharmacokinetic parameters of HSK21542 in plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | From after administration to the end of telephone follow-up | The incidence and severity of AEs |
| The main metabolites of HSK21542 | From the start of administration to 168 hours after administration | The main metabolites of HSK21542 in plasma, urine, feces, and dialysate |
Countries
China
Outcome results
None listed