A Multicenter, Randomised, Double-blind, Double-dummy Study to Assess the Efficacy and Safety of SHR6508 in Hemodialysis Subjects With Secondary Hyperparathyroidism

SHR6508-301

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.

2024-06-01

2025-06-01

2025-07-01

Not yet recruiting

Early phase I

486

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 486, 'type': 'ESTIMATED'}}

2024-05-30