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

SHR6508-202

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.

2024-02-20

2025-12-01

2025-12-01

Recruiting

Early phase I

300

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}

2024-03-05