Secondary Hyperparathyroidism
Conditions
Brief summary
The study is being conducted to evaluate the efficacy and safety of SHR6508 among Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis.
Interventions
DRUGSHR6508 plus oral placebo tablets
SHR6508 plus oral placebo tablets
DRUGCinacalcet plus intravenous placebo
Cinacalcet plus intravenous placebo
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide a written informed consent 2. Diagnosed with end stage renal disease receiving maintenance hemodialysis 3. Male or female 4. Meet the Body Mass Index standard 5. Stably use of concomitant medication of other therapies of SHPT 6. Meet the standard of iPTH level, cCa
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. Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin 8. Subjects with a treatment history of similar drugs 9. Allergic to a drug ingredient or component 10. Pregnant or nursing women 11. No birth control during the specified period of time 12. Subject with a history of alcohol abuse and drug abuse 13. Participated in clinical trials of other drugs 14. The investigators determined that other conditions were inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants to End of Study whose iPTH decreased by>30% from baseline | efficacy assessment period, defined as Week 20-27 | iPTH was tested at a central laboratory. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of nausea and vomiting events | Day1 to End of Treatment, End of Treatment is about Week 27 | Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA) |
| Proportion of Participants to End of Treatment whose iPTH decreased to 300 pg/mL from baseline | efficacy assessment period, defined as Week 20-27 | iPTH was tested at a central laboratory. |
| Proportion of Participants to End of Study whose iPTH decreased by>50% from baseline | efficacy assessment period, defined as Week 20-27 | iPTH was tested at a central laboratory. |
| Participants With Treatment-Emergent Adverse Events (TEAEs) | Day1 to End of Study, End of Study is about Week 31 | Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA) |
| Participants with Anti-SHR6508 Antibody at baseline and postbaseline | Day1 to End of Study, End of Study is about Week 31 | Anti-SHR6508 Antibody was measured in patient serum samples using a validated enzyme-linked immunosorbent assay (ELISA) method. |
| Change From Baseline in serum cCa and P | efficacy assessment period, defined as Week 20-27 | cCa and P were tested at a central laboratory. |
Countries
China
Outcome results
None listed