A Study of SHR6508 in Secondary Hyperparathyroidism

Secondary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05663411
• Other study ID #: SHR6508-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 24, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: November 2022
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: November 30, 2023
• Est. primary completion date: October 31, 2023
• 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 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• SHR6508
SHR6508
• SHR6508
SHR6508
• Cinacalcet
Cinacalcet

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	Change From Baseline in serum iPTH	iPTH was tested at a central laboratory.	Baseline and the efficacy period, defined as Week 16
Secondary	Proportion of Participants to End of Study whose iPTH decreased by=30% from baseline	iPTH was tested at a central laboratory.	Baseline and the efficacy period, defined as Week 16
Secondary	Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline	iPTH was tested at a central laboratory.	Baseline and the efficacy period, defined as Week 16
Secondary	Change From Baseline in serum cCa and P	cCa and P were tested at a local laboratory.	Baseline and the efficacy period, defined as Week 16
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 20
Secondary	Participants with Anti-SHR6508 Antibody at baseline and postbaseline		Day1 to End of Study, End of Study is about Week 20