A Study of SHR6508 in Secondary Hyperparathyroidism

• Status: Not yet recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Treatments: Cinacalcet

Criteria

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