Secondary Hyperparathyroidism
Conditions
Brief summary
The study is being conducted to evaluate the tolerability, pharmacokinetics and pharmacodynamics of SHR6508 for Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis
Interventions
DRUGSHR6508；Placebo
Group A:SHR6508 low dose
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
SHR6508 compared with placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide a written informed consent 2. Diagnosed with end stage renal disease receiving stable hemodialysis 3. Male or female 4. Meet the Body Mass Index standard 5. Conform to the ASA Physical Status Classification 6. Stably use of concomitant medication of other therapies of SHPT 7. Meet the standard of iPTH level, cCa and HB
Exclusion criteria
1. Subjects with a history of malignant tumor 2. Subjects with neuropsychiatric diseases 3. Subjects with a history of cardiovascular diseases 4. Subjects with gastrointestinal diseases 5. Subjects with a history of surgery 6. Subjects with a history of blood loss 7. Subjects with a history of parathyroidectomy or planned during the study 8. Subjects with a history of kidney transplant or planned during the study 9. Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin, platelet counts. 10. Subjects with a treatment history of similar drugs 11. Allergic to a drug ingredient or component 12. Pregnant or nursing women 13. No birth control during the specified period of time 14. Subject with a history of alcohol abuse and drug abuse 15. Participated in clinical trials of other drugs (received experimental drugs) 16. The investigators determined that other conditions were inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accumulation Ratio | Day1-Day29(if reach steady-state) |
| t1/2z,ss, Terminal elimination half-life at steady-state | Day1-Day29(if reach steady-state) |
| CLss, Total Body Clearance at steady-state. | Day1-Day29(if reach steady-state) |
| Vss, Volume of distribution based on the terminal phase at steady-state. | Day1-Day29(if reach steady-state) |
| MRT0-∞, Mean residence time from time 0 extrapolated to infinite time. | Day1-Day29(if reach steady-state) |
| DF: Degree of Fluctuation | Day1-Day29(if reach steady-state) |
| Tmax, Time of maximum observed concentration. | 0 hour to 43 hours after first dose administration |
| Cmax, Maximum observed concentration. | 0 hour to 43 hours after first dose administration |
| AUC0-t, Area under the concentration-time curve from time zero to the last measurable concentration. | 0 hour to 43 hours after first dose administration |
| AUC0-∞, Area under the curve from time 0 extrapolated to infinite time | 0 hour to 43 hours after first dose administration |
| t1/2z, Terminal elimination half-life | 0 hour to 43 hours after first dose administration |
| CLz, Total Body Clearance | 0 hour to 43 hours after first dose administration |
| Vz, Volume of distribution based on the terminal phase | 0 hour to 43 hours after first dose administration |
| MRT0-t, Mean residence time from time zero to the last measurable concentration. | 0 hour to 43 hours after first dose administration |
| MRT0-∞, Mean residence time from time 0 extrapolated to infinite time | 0 hour to 43 hours after first dose administration |
| Cmax,ss : Maximum observed concentration at steady-state. | Day1-Day29(if reach steady-state) |
| Cmin,ss : Minimum observed concentration at steady-state | Day1-Day29(if reach steady-state) |
| Cav : Average concentration | Day1-Day29(if reach steady-state) |
| AUC0-t,ss, Area under the concentration-time curve from time zero to the last measurable concentration at steady-state. | Day1-Day29(if reach steady-state) |
| AUC0-∞,ss, Area under the concentration-time curve from time 0 extrapolated to infinite time at steady-state. | Day1-Day29(if reach steady-state) |
| Tmax,ss, Time of maximum observed concentration at steady-state. | Day1-Day29(if reach steady-state) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to End of Study in serum iPTH, cCa, P, FGF23 and BSAP | Day1 to Day29 | iPTH, FGF23 and BSAP were tested at a central laboratory. |
| Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline | Day1 to Day29 | iPTH was tested at a central laboratory. |
| Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline | Day1 to Day29 | iPTH was tested at a central laboratory |
| Participants With Treatment-Emergent Adverse Events (TEAEs) | Day1 to End of Study, End of Study is about Day55 | Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA) |
| Change From Baseline in serum iPTH, cCa, P, FGF23 and BSAP | 0 hour to 43 hours after first dose administration | iPTH, FGF23 and BSAP were tested at a central laboratory. |
Countries
China
Outcome results
None listed