A Study of SHR6508 in Secondary Hyperparathyroidism

Phase 2

Active, not recruiting

• Conditions: Secondary Hyperparathyroidism
• Interventions: Drug: SHR6508; Drug: Cinacalcet

• Registration Number: NCT05663411
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2022-12-23
• Study Start: 2023-02-24
• Last Update Submitted: 2023-06-16
• Last Update Posted: 2023-06-18
• Primary Completion: 2023-10-31
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group B: SHR6508	SHR6508	-
Treatment group A: SHR6508	SHR6508	-
Treatment group C: Cinacalcet	Cinacalcet	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in serum iPTH	Baseline and the efficacy period, defined as Week 16	iPTH was tested at a central laboratory.

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline	Baseline and the efficacy period, defined as Week 16	iPTH was tested at a central laboratory.
Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline	Baseline and the efficacy period, defined as Week 16	iPTH was tested at a central laboratory.
Change From Baseline in serum cCa and P	Baseline and the efficacy period, defined as Week 16	cCa and P were tested at a local laboratory.
Participants With Treatment-Emergent Adverse Events (TEAEs)	Day1 to End of Study, End of Study is about Week 20	Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)
Participants with Anti-SHR6508 Antibody at baseline and postbaseline	Day1 to End of Study, End of Study is about Week 20

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China