An Open-label, Randomized, Active-Controlled Dose Titration Study to Assess the Efficacy and Safety of SHR6508 in Hemodialysis Subjects With Secondary Hyperparathyroidism

SHR6508-201

The study is being conducted to evaluate the efficacy and safety of SHR6508 for Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis.

2023-02-24

2023-10-31

2023-11-30

Active (not recruiting)

Early phase I

75

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. Stably use of concomitant medication of other therapies of SHPT 6. 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 kidney transplant 8. Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin 9. Subjects with a treatment history of similar drugs 10. Allergic to a drug ingredient or component 11. Pregnant or nursing women 12. No birth control during the specified period of time 13. Subject with a history of alcohol abuse and drug abuse 14. Participated in clinical trials of other drugs 15. The investigators determined that other conditions were inappropriate for participation in this clinical trial

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 75, 'type': 'ACTUAL'}}

2023-06-18