NCT06236295已完成2 期
Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- Incidence and severity of any adverse events that occurred during the clinical study
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
SHR6508
Experimental
干预措施: SHR6508 (Drug)
结局指标
主要结局
Incidence and severity of any adverse events that occurred during the clinical study
时间窗: through study completion, an average of 1 year
次要结局
- 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)
研究者
研究点 (1)
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