Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial

Phase 2

Active, not recruiting

• Conditions: Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
• Interventions: Drug: SHR6508

• Registration Number: NCT06236295
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Brief Summary

This is a multicenter, single-arm, long-term safety and tolerability trial. A total of 300 subjects with chronic kidney disease on hemodialysis are planned to be enrolled.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-09
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-02-01
• Study Start: 2024-02-20
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 303

Inclusion Criteria

1. Subject is 18 years of age or older
2. Subject understands the study procedures and agrees to participate in thestudy by giving written informed consent.
3. Subject must be receiving regular hemodialysis for at least 12 weeks
4. BMI ≥18 kg/m2 and ≤35 kg/m2
5. iPTH≥ 300pg/ mL

Exclusion Criteria

1. Subject has received a a history of malignant tumor within 5 years prior to screening
2. Subject has a history of unstable angina, congestive heart failure (NYHA class III or IV), acute myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening.
3. Postdialysis systolic blood pressure>180 mmHg and/or diastolic blood pressure>110 mmHg
4. Allergy to the investigational drug (SHR6508 injection) and any of its components or excipients
5. Subject has a history of drug use or excessive alcohol use within 6 months prior to screening
6. Female subjects who were pregnant or lactating
7. Other reasons for not participating as deemed by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR6508	SHR6508	-

Primary Outcome Measures

Name	Time	Method
Incidence and severity of any adverse events that occurred during the clinical study	through study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline in predialysis iPTH during the EAP	through study completion, an average of 1 year
Percent change from baseline in predialysis serum cCa during the EAP	through study completion, an average of 1 year
Percent change from baseline in predialysis serum phosphorus during the EAP	through study completion, an average of 1 year
Percent change from baseline in predialysis calcium-phosphorus product during the EAP	through study completion, an average of 1 year

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China