NCT06236295CompletedPhase 2
Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial
Shanghai Hengrui Pharmaceutical Co., Ltd.1 site in 1 country303 target enrollmentStarted: February 20, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 303
- Locations
- 1
- Primary Endpoint
- Incidence and severity of any adverse events that occurred during the clinical study
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is 18 years of age or older
- •Subject understands the study procedures and agrees to participate in thestudy by giving written informed consent.
- •Subject must be receiving regular hemodialysis for at least 12 weeks
- •BMI ≥18 kg/m2 and ≤35 kg/m2
- •iPTH≥ 300pg/ mL
Exclusion Criteria
- •Subject has received a a history of malignant tumor within 5 years prior to screening
- •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.
- •Postdialysis systolic blood pressure>180 mmHg and/or diastolic blood pressure>110 mmHg
- •Allergy to the investigational drug (SHR6508 injection) and any of its components or excipients
- •Subject has a history of drug use or excessive alcohol use within 6 months prior to screening
- •Female subjects who were pregnant or lactating
- •Other reasons for not participating as deemed by the investigator
Arms & Interventions
SHR6508
Experimental
Intervention: SHR6508 (Drug)
Outcomes
Primary Outcomes
Incidence and severity of any adverse events that occurred during the clinical study
Time Frame: through study completion, an average of 1 year
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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