The Trial of SHR6508 in Secondary Hyperparathyroidism

Secondary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06434961
• Other study ID #: SHR6508-301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: Kunming Li
• Phone: 0518-82342973
• Email: kunming.li[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 486
• Est. completion date: July 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Intervention

Drug:
• SHR6508 plus oral placebo tablets
SHR6508 plus oral placebo tablets
• Cinacalcet plus intravenous placebo
Cinacalcet plus intravenous placebo

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants to End of Study whose iPTH decreased by>30% from baseline	iPTH was tested at a central laboratory.	efficacy assessment period, defined as Week 20-27
Secondary	Proportion of Participants to End of Study whose iPTH decreased by>50% from baseline	iPTH was tested at a central laboratory.	efficacy assessment period, defined as Week 20-27
Secondary	Incidence of nausea and vomiting events	Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)	Day1 to End of Treatment, End of Treatment is about Week 27
Secondary	Proportion of Participants to End of Treatment whose iPTH decreased to 300 pg/mL from baseline	iPTH was tested at a central laboratory.	efficacy assessment period, defined as Week 20-27
Secondary	Change From Baseline in serum cCa and P	cCa and P were tested at a central laboratory.	efficacy assessment period, defined as Week 20-27
Secondary	Participants With Treatment-Emergent Adverse Events (TEAEs)	Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)	Day1 to End of Study, End of Study is about Week 31
Secondary	Participants with Anti-SHR6508 Antibody at baseline and postbaseline	Anti-SHR6508 Antibody was measured in patient serum samples using a validated enzyme-linked immunosorbent assay (ELISA) method.	Day1 to End of Study, End of Study is about Week 31