The Trial of SHR6508 in Secondary Hyperparathyroidism

Phase 3

Recruiting

• Conditions: Secondary Hyperparathyroidism
• Interventions: Drug: Cinacalcet plus intravenous placebo; Drug: SHR6508 plus oral placebo tablets

• Registration Number: NCT06434961
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-24
• Study First Submitted QC: 2024-05-24
• Study First Posted: 2024-05-30
• Study Start: 2024-06-14
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 486

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Control group	Cinacalcet plus intravenous placebo	-
Treatment group	SHR6508 plus oral placebo tablets	-

Primary Outcome Measures

Name	Time	Method
Proportion of Participants to End of Study whose iPTH decreased by>30% from baseline	efficacy assessment period, defined as Week 20-27	iPTH was tested at a central laboratory.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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