NCT06434961已完成3 期
A Multicenter, Randomised, Double-blind, Double-dummy Study to Assess the Efficacy and Safety of SHR6508 in Hemodialysis Subjects With Secondary Hyperparathyroidism
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 498
- 试验地点
- 1
- 主要终点
- Proportion of Participants to End of Study whose iPTH decreased by>30% from baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Able and willing to provide a written informed consent
- •Diagnosed with end stage renal disease receiving maintenance hemodialysis
- •Male or female
- •Meet the Body Mass Index standard
- •Stably use of concomitant medication of other therapies of SHPT
- •Meet the standard of iPTH level, cCa
排除标准
- •Subjects with a history of malignant tumor
- •Subjects with neuropsychiatric diseases
- •Subjects with a history of cardiovascular diseases
- •Subjects with gastrointestinal diseases
- •Subjects with a history of surgery
- •Subjects with a history of blood loss
- •Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin
- •Subjects with a treatment history of similar drugs
- •Allergic to a drug ingredient or component
- •Pregnant or nursing women
- •No birth control during the specified period of time
- •Subject with a history of alcohol abuse and drug abuse
- •Participated in clinical trials of other drugs
- •The investigators determined that other conditions were inappropriate for participation in this clinical trial
研究组 & 干预措施
Treatment group
Experimental
干预措施: SHR6508 plus oral placebo tablets (Drug)
Active Control group
Active Comparator
干预措施: Cinacalcet plus intravenous placebo (Drug)
结局指标
主要结局
Proportion of Participants to End of Study whose iPTH decreased by>30% from baseline
时间窗: efficacy assessment period, defined as Week 20-27
iPTH was tested at a central laboratory.
次要结局
- Proportion of Participants to End of Study whose iPTH decreased by>50% from baseline(efficacy assessment period, defined as Week 20-27)
- Proportion of Participants to End of Treatment whose iPTH decreased to 300 pg/mL from baseline(efficacy assessment period, defined as Week 20-27)
- Participants with Anti-SHR6508 Antibody at baseline and postbaseline(Day1 to End of Study, End of Study is about Week 31)
- Change From Baseline in serum cCa and P(efficacy assessment period, defined as Week 20-27)
- Incidence of nausea and vomiting events(Day1 to End of Treatment, End of Treatment is about Week 27)
- Participants With Treatment-Emergent Adverse Events (TEAEs)(Day1 to End of Study, End of Study is about Week 31)
研究者
研究点 (1)
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